Science.gov

Sample records for 2012-04-01 false medical

  1. 21 CFR 880.6430 - Liquid medication dispenser.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Liquid medication dispenser. 880.6430 Section 880... Devices § 880.6430 Liquid medication dispenser. (a) Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication....

  2. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical neutron radiation therapy system. 892.5300... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron radiation therapy system. (a) Identification. A medical neutron radiation therapy system is a device intended...

  3. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  4. 21 CFR 558.5 - Requirements for liquid medicated feed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Requirements for liquid medicated feed. 558.5... Provisions § 558.5 Requirements for liquid medicated feed. (a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed: (1) Type B...

  5. 21 CFR 880.6710 - Medical ultraviolet water purifier.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical ultraviolet water purifier. 880.6710... Miscellaneous Devices § 880.6710 Medical ultraviolet water purifier. (a) Identification. A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water...

  6. 20 CFR 702.414 - Fees for medical services; unresolved disputes on prevailing charges.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... incorrectly identified by medical procedure code; (ii) that the presence of a severe or concomitant medical... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Fees for medical services; unresolved... ADMINISTRATION AND PROCEDURE Medical Care and Supervision § 702.414 Fees for medical services;...

  7. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  8. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  9. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device....

  10. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image digitizer. 892.2030 Section 892.2030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer....

  11. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  12. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  13. 26 CFR 1.213-1 - Medical, dental, etc., expenses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 3 2012-04-01 2012-04-01 false Medical, dental, etc., expenses. 1.213-1 Section... (CONTINUED) INCOME TAXES (CONTINUED) Additional Itemized Deductions for Individuals § 1.213-1 Medical, dental... treatment of expenses paid for medical care. (iii) The application of the rule allowing a deduction...

  14. 21 CFR 640.62 - Medical supervision.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Medical supervision. 640.62 Section 640.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.62 Medical supervision....

  15. 20 CFR 404.1526 - Medical equivalence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical equivalence. 404.1526 Section 404.1526 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical Considerations § 404.1526...

  16. 20 CFR 30.701 - How are medical bills to be submitted?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false How are medical bills to be submitted? 30.701... EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000, AS AMENDED Information for Medical Providers Medical Records and Bills § 30.701 How are medical bills to be submitted? (a) All charges...

  17. 20 CFR 702.422 - Effect of failure to report on medical care after initial authorization.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Effect of failure to report on medical care... ADMINISTRATION AND PROCEDURE Medical Care and Supervision Medical Procedures § 702.422 Effect of failure to... authorization of such medical care provider. The effect of a final finding to this effect operates to...

  18. 20 CFR 702.415 - Fees for medical services; unresolved disputes on charges; procedure.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Fees for medical services; unresolved... ADMINISTRATION AND PROCEDURE Medical Care and Supervision § 702.415 Fees for medical services; unresolved... seek a hearing pursuant to section 556 of title 5, United States Code. Upon written request for such...

  19. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  20. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; prominence of required label... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  1. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... shipment or other delivery of a device which is, in accordance with the practice of the trade, to...

  2. 20 CFR 416.926 - Medical equivalence for adults and children.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical equivalence for adults and children. 416.926 Section 416.926 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY... § 416.926 Medical equivalence for adults and children. (a) What is medical equivalence? Your...

  3. 21 CFR 880.6350 - Battery-powered medical examination light.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6350 Battery-powered medical examination light. (a) Identification... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Battery-powered medical examination light....

  4. 21 CFR 870.2800 - Medical magnetic tape recorder.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical magnetic tape recorder. 870.2800 Section 870.2800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... magnetic tape recorder. (a) Identification. A medical magnetic tape recorder is a device used to record...

  5. 18 CFR 1301.16 - Special procedures-medical records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 2 2012-04-01 2012-04-01 false Special procedures-medical records. 1301.16 Section 1301.16 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES Privacy Act § 1301.16 Special procedures—medical records. If, in the judgment of...

  6. 21 CFR 21.33 - Medical records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Medical records. 21.33 Section 21.33 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF... maintained by the Food and Drug Administration. (b) The Food and Drug Administration may apply the...

  7. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; name and place of business of..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a)...

  8. 21 CFR 20.63 - Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... research subjects in any medical or similar report, test, study, or other research project shall be deleted... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Personnel, medical, and similar files, disclosure... Exemptions § 20.63 Personnel, medical, and similar files, disclosure of which constitutes a...

  9. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  10. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c)....

  11. 22 CFR 96.49 - Provision of medical and social information in incoming cases.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Provision of medical and social information in... United States (incoming Cases) § 96.49 Provision of medical and social information in incoming cases. (a... factors in the child's country of origin; and (6) Current health information. (f) The agency or...

  12. 21 CFR 870.2450 - Medical cathode-ray tube display.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical cathode-ray tube display. 870.2450 Section 870.2450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... cathode-ray tube display. (a) Identification. A medical cathode-ray tube display is a device...

  13. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG...

  14. 20 CFR 725.701 - Availability of medical benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Availability of medical benefits. 725.701 Section 725.701 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF...

  15. 21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510... copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing...

  16. 20 CFR 10.337 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 10.337... for a medical expense, must the provider refund the balance of the amount paid to the employee?...

  17. 20 CFR 30.911 - Does maximum medical improvement always have to be reached for an impairment to be included in...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Does maximum medical improvement always have to be reached for an impairment to be included in the impairment rating? 30.911 Section 30.911... Ratable Impairments § 30.911 Does maximum medical improvement always have to be reached for an...

  18. 20 CFR Appendix 2 to Subpart P of... - Medical-Vocational Guidelines

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical-Vocational Guidelines 2 Appendix 2 to Subpart P of Part 404 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Pt. 404, Subpt. P, App. 2 Appendix 2...

  19. 20 CFR 404.1516 - If you fail to submit medical and other evidence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false If you fail to submit medical and other evidence. 404.1516 Section 404.1516 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Evidence § 404.1516 If...

  20. 20 CFR 404.1569 - Listing of Medical-Vocational Guidelines in appendix 2.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Listing of Medical-Vocational Guidelines in appendix 2. 404.1569 Section 404.1569 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Vocational...

  1. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices having commonly known directions. 801.116 Section 801.116 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  2. 20 CFR 416.962 - Medical-vocational profiles showing an inability to make an adjustment to other work.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical-vocational profiles showing an inability to make an adjustment to other work. 416.962 Section 416.962 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Determining Disability and Blindness Vocational Considerations...

  3. 20 CFR 416.996 - Continued disability or blindness benefits pending appeal of a medical cessation determination.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Continued disability or blindness benefits... Disability and Blindness Continuing Or Stopping Disability Or Blindness § 416.996 Continued disability or blindness benefits pending appeal of a medical cessation determination. (a) General. If we determine...

  4. 20 CFR 404.1562 - Medical-vocational profiles showing an inability to make an adjustment to other work.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Medical-vocational profiles showing an inability to make an adjustment to other work. 404.1562 Section 404.1562 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and...

  5. 20 CFR 30.113 - What are the requirements for written medical documentation, contemporaneous records, and other...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false What are the requirements for written medical documentation, contemporaneous records, and other records or documents? 30.113 Section 30.113 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF LABOR ENERGY EMPLOYEES...

  6. 21 CFR 880.6260 - Filtering facepiece respirator for use by the general public in public health medical emergencies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Filtering facepiece respirator for use by the... Filtering facepiece respirator for use by the general public in public health medical emergencies. (a) Identification. A filtering facepiece respirator for use by the general public in public health...

  7. 20 CFR 30.422 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 30.422... provider refund the balance of the amount paid to the employee? (a) The OWCP fee schedule sets...

  8. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Where can I find the reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG... the coding manual from CDRH's Web site at...

  9. 20 CFR 702.217 - Penalty for false statement, misrepresentation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Penalty for false statement, misrepresentation. 702.217 Section 702.217 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF LABOR LONGSHOREMEN'S AND HARBOR WORKERS' COMPENSATION ACT AND RELATED STATUTES ADMINISTRATION...

  10. 25 CFR 700.541 - Fraud or false statement in a Government matter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false Fraud or false statement in a Government matter. 700.541... matter. “Whoever, in any matter within the jurisdiction of any department or agency of the United States..., applications for employment, personnel security forms, requests for travel reimbursement, client...

  11. 21 CFR 884.6150 - Assisted reproduction micromanipulators and microinjectors.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Assisted reproduction micromanipulators and... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6150 Assisted reproduction micromanipulators and microinjectors. (a)...

  12. 21 CFR 884.6140 - Assisted reproduction micropipette fabrication instruments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Assisted reproduction micropipette fabrication... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6140 Assisted reproduction micropipette fabrication instruments. (a)...

  13. 20 CFR 30.701 - How are medical bills to be submitted?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true How are medical bills to be submitted? 30.701... EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000, AS AMENDED Information for Medical Providers Medical Records and Bills § 30.701 How are medical bills to be submitted? (a) All charges...

  14. 18 CFR 1301.16 - Special procedures-medical records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 2 2013-04-01 2012-04-01 true Special procedures-medical records. 1301.16 Section 1301.16 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES Privacy Act § 1301.16 Special procedures—medical records. If, in the judgment of...

  15. An estimate of the science-wise false discovery rate and application to the top medical literature.

    PubMed

    Jager, Leah R; Leek, Jeffrey T

    2014-01-01

    The accuracy of published medical research is critical for scientists, physicians and patients who rely on these results. However, the fundamental belief in the medical literature was called into serious question by a paper suggesting that most published medical research is false. Here we adapt estimation methods from the genomics community to the problem of estimating the rate of false discoveries in the medical literature using reported $P$-values as the data. We then collect $P$-values from the abstracts of all 77 430 papers published in The Lancet, The Journal of the American Medical Association, The New England Journal of Medicine, The British Medical Journal, and The American Journal of Epidemiology between 2000 and 2010. Among these papers, we found 5322 reported $P$-values. We estimate that the overall rate of false discoveries among reported results is 14% (s.d. 1%), contrary to previous claims. We also found that there is no a significant increase in the estimated rate of reported false discovery results over time (0.5% more false positives (FP) per year, $P = 0.18$) or with respect to journal submissions (0.5% more FP per 100 submissions, $P = 0.12$). Statistical analysis must allow for false discoveries in order to make claims on the basis of noisy data. But our analysis suggests that the medical literature remains a reliable record of scientific progress.

  16. 20 CFR 10.337 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 10.337... for a medical expense, must the provider refund the balance of the amount paid to the employee?...

  17. 20 CFR 10.337 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 10.337... for a medical expense, must the provider refund the balance of the amount paid to the employee?...

  18. 20 CFR 30.911 - Does maximum medical improvement always have to be reached for an impairment to be included in...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true Does maximum medical improvement always have to be reached for an impairment to be included in the impairment rating? 30.911 Section 30.911... Ratable Impairments § 30.911 Does maximum medical improvement always have to be reached for an...

  19. 20 CFR 30.911 - Does maximum medical improvement always have to be reached for an impairment to be included in...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true Does maximum medical improvement always have to be reached for an impairment to be included in the impairment rating? 30.911 Section 30.911... Ratable Impairments § 30.911 Does maximum medical improvement always have to be reached for an...

  20. 20 CFR 30.113 - What are the requirements for written medical documentation, contemporaneous records, and other...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true What are the requirements for written medical documentation, contemporaneous records, and other records or documents? 30.113 Section 30.113 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF LABOR ENERGY EMPLOYEES...

  1. 21 CFR 810.18 - Public notice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Public notice. 810.18 Section 810.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.18 Public notice....

  2. 20 CFR 30.422 - If an employee is only partially reimbursed for a medical expense, must the provider refund the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true If an employee is only partially reimbursed for a medical expense, must the provider refund the balance of the amount paid to the employee? 30.422... provider refund the balance of the amount paid to the employee? (a) The OWCP fee schedule sets...

  3. 21 CFR 864.1850 - Dye and chemical solution stains.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dye and chemical solution stains. 864.1850 Section... (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Biological Stains § 864.1850 Dye and chemical solution stains. (a) Identification. Dye and chemical solution stains for medical purposes are mixtures...

  4. 21 CFR 868.5220 - Blow bottle.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blow bottle. 868.5220 Section 868.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... that is intended for medical purposes to induce a forced expiration from a patient. The patient...

  5. 21 CFR 868.5240 - Anesthesia breathing circuit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anesthesia breathing circuit. 868.5240 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5240 Anesthesia breathing circuit. (a) Identification. An anesthesia breathing circuit is a device that is intended to administer medical gases to...

  6. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure...

  7. 21 CFR 814.106 - HDE amendments and resubmitted HDE's.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false HDE amendments and resubmitted HDE's. 814.106 Section 814.106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.106...

  8. 21 CFR 814.122 - Confidentiality of data and information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Confidentiality of data and information. 814.122 Section 814.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices §...

  9. 21 CFR 814.110 - New indications for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false New indications for use. 814.110 Section 814.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.110 New...

  10. 21 CFR 814.108 - Supplemental applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Supplemental applications. 814.108 Section 814.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.108...

  11. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Do I need to submit reports in English? 803.13 Section 803.13 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.13 Do I need to submit...

  12. 21 CFR 803.14 - How do I submit a report electronically?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false How do I submit a report electronically? 803.14 Section 803.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.14 How do I submit a...

  13. 21 CFR 814.114 - Timeframes for reviewing an HDE.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Timeframes for reviewing an HDE. 814.114 Section 814.114 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices §...

  14. 21 CFR 814.120 - Temporary suspension of approval of an HDE.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Temporary suspension of approval of an HDE. 814.120 Section 814.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices §...

  15. 21 CFR 808.55 - California.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false California. 808.55 Section 808.55 Food and Drugs... and Local Exemptions § 808.55 California. (a) The following California medical device requirements are... following California medical device requirements are preempted by section 521 of the act, and FDA has...

  16. 21 CFR 864.9875 - Transfer set.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Transfer set. 864.9875 Section 864.9875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... § 864.9875 Transfer set. (a) Identification. A transfer set is a device intended for medical...

  17. 21 CFR 868.2620 - Gas pressure calibrator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas pressure calibrator. 868.2620 Section 868.2620...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2620 Gas pressure calibrator. (a) Identification. A gas pressure calibrator is a device intended for medical purposes that is used to...

  18. 21 CFR 868.2900 - Gas pressure transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas pressure transducer. 868.2900 Section 868.2900...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2900 Gas pressure transducer. (a) Identification. A gas pressure transducer is a device intended for medical purposes that is used to convert...

  19. 21 CFR 890.5950 - Powered heating unit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered heating unit. 890.5950 Section 890.5950...) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5950 Powered heating unit. (a) Identification. A powered heating unit is a device intended for medical purposes...

  20. 20 CFR 30.412 - Who pays for second opinion and referee examinations?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Who pays for second opinion and referee... Related Benefits Directed Medical Examinations § 30.412 Who pays for second opinion and referee examinations? OWCP will pay second opinion and referee medical specialists directly. OWCP will also...

  1. 21 CFR 808.59 - Florida.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Florida. 808.59 Section 808.59 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Listing of Specific State and Local Exemptions § 808.59 Florida....

  2. 21 CFR 26.64 - Transitional arrangements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Transitional arrangements. 26.64 Section 26.64 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE...

  3. 21 CFR 26.81 - Final provisions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Final provisions. 26.81 Section 26.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT...

  4. 21 CFR 26.77 - Fees.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Fees. 26.77 Section 26.77 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS:...

  5. 21 CFR 26.79 - Territorial application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Territorial application. 26.79 Section 26.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE...

  6. 21 CFR 892.1640 - Radiographic film marking system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film marking system. 892.1640 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1640 Radiographic film marking system. (a) Identification. A radiographic film marking system is a device intended for medical purposes...

  7. 21 CFR 800.10 - Contact lens solutions; sterility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Contact lens solutions; sterility. 800.10 Section...) MEDICAL DEVICES GENERAL Requirements for Specific Medical Devices § 800.10 Contact lens solutions... ophthalmic use, including contact lens solutions, should be sterile. It is further evident that...

  8. 21 CFR 890.1450 - Powered reflex hammer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered reflex hammer. 890.1450 Section 890.1450...) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1450 Powered reflex hammer. (a) Identification. A powered reflex hammer is a motorized device intended for medical...

  9. 21 CFR 868.5300 - Carbon dioxide absorbent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carbon dioxide absorbent. 868.5300 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5300 Carbon dioxide absorbent. (a) Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of...

  10. 21 CFR 868.5310 - Carbon dioxide absorber.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carbon dioxide absorber. 868.5310 Section 868.5310...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5310 Carbon dioxide absorber. (a) Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in...

  11. 21 CFR 801.420 - Hearing aid devices; professional and patient labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hearing aid devices; professional and patient... a waiver statement declining the medical evaluation for religious or personal beliefs that preclude... strongly discouraged. children with hearing loss In addition to seeing a physician for a medical...

  12. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Aqueous shunt. 886.3920 Section 886.3920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed....

  13. 21 CFR 868.2340 - Compensated thorpe tube flowmeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Compensated thorpe tube flowmeter. 868.2340... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2340 Compensated thorpe tube flowmeter. (a) Identification. A compensated thorpe tube flowmeter is a device intended for medical...

  14. 21 CFR 1040.11 - Specific purpose laser products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Specific purpose laser products. 1040.11 Section...) RADIOLOGICAL HEALTH PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS § 1040.11 Specific purpose laser products. (a) Medical laser products. Each medical laser product shall comply with all of the...

  15. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiation therapy simulation system. 892.5840... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy simulation system. (a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic...

  16. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  17. 21 CFR 886.5100 - Ophthalmic beta radiation source.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply...

  18. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  19. 21 CFR 892.5900 - X-ray radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false X-ray radiation therapy system. 892.5900 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5900 X-ray radiation therapy system. (a) Identification. An x-ray radiation therapy system is a device intended to produce and control...

  20. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic...

  1. 21 CFR 225.10 - Personnel.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Personnel. 225.10 Section 225.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.10 Personnel....

  2. 21 CFR 225.202 - Formula, production, and distribution records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Formula, production, and distribution records. 225.202 Section 225.202 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records §...

  3. 21 CFR 225.180 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Labeling. 225.180 Section 225.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Labeling § 225.180 Labeling. Labels shall...

  4. 21 CFR 895.101 - Prosthetic hair fibers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic hair fibers. 895.101 Section 895.101...) MEDICAL DEVICES BANNED DEVICES Listing of Banned Devices § 895.101 Prosthetic hair fibers. Prosthetic hair fibers are devices intended for implantation into the human scalp to simulate natural hair or...

  5. 21 CFR 886.1160 - Color vision plate illuminator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Color vision plate illuminator. 886.1160 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1160 Color vision plate illuminator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp...

  6. 21 CFR 866.4070 - RNA Preanalytical Systems.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false RNA Preanalytical Systems. 866.4070 Section 866.4070 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents §...

  7. 21 CFR 866.3210 - Endotoxin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endotoxin assay. 866.3210 Section 866.3210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3210 Endotoxin assay....

  8. 21 CFR 866.3405 - Poliovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Poliovirus serological reagents. 866.3405 Section 866.3405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3405...

  9. 21 CFR 866.4830 - Rocket immunoelectro-phoresis equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rocket immunoelectro-phoresis equipment. 866.4830 Section 866.4830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and...

  10. 21 CFR 866.2420 - Oxidase screening test for gonorrhea.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxidase screening test for gonorrhea. 866.2420 Section 866.2420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2420...

  11. 21 CFR 866.3110 - Campylobacter fetus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Campylobacter fetus serological reagents. 866.3110 Section 866.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3110...

  12. 21 CFR 866.3490 - Rhinovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rhinovirus serological reagents. 866.3490 Section 866.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3490...

  13. 21 CFR 866.3135 - Coccidioides immitis serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Coccidioides immitis serological reagents. 866.3135 Section 866.3135 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  14. 21 CFR 866.3480 - Respiratory syncytial virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Respiratory syncytial virus serological reagents. 866.3480 Section 866.3480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  15. 21 CFR 866.3370 - Mycobacterium tuberculosis immunofluorescent reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mycobacterium tuberculosis immunofluorescent reagents. 866.3370 Section 866.3370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological...

  16. 21 CFR 866.3140 - Corynebacterium spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Corynebacterium spp. serological reagents. 866.3140 Section 866.3140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  17. 21 CFR 866.3395 - Norovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Norovirus serological reagents. 866.3395 Section 866.3395 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3395...

  18. 21 CFR 866.3060 - Blastomyces dermatitidis serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blastomyces dermatitidis serological reagents. 866.3060 Section 866.3060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  19. 21 CFR 866.2170 - Automated colony counter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated colony counter. 866.2170 Section 866.2170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2170 Automated...

  20. 21 CFR 866.2850 - Automated zone reader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated zone reader. 866.2850 Section 866.2850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2850 Automated zone...

  1. 21 CFR 866.3280 - Francisella tularensis serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Francisella tularensis serological reagents. 866.3280 Section 866.3280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  2. 21 CFR 866.3200 - Echinococcus spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Echinococcus spp. serological reagents. 866.3200 Section 866.3200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3200...

  3. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND...

  4. 21 CFR 866.3175 - Cytomegalovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cytomegalovirus serological reagents. 866.3175 Section 866.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  5. 21 CFR 866.3350 - Leptospira spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Leptospira spp. serological reagents. 866.3350 Section 866.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3350...

  6. 21 CFR 866.3040 - Aspergillus spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Aspergillus spp. serological reagents. 866.3040 Section 866.3040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3040...

  7. 21 CFR 866.2500 - Microtiter diluting and dispensing device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microtiter diluting and dispensing device. 866.2500 Section 866.2500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices §...

  8. 21 CFR 866.3400 - Parainfluenza virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Parainfluenza virus serological reagents. 866.3400 Section 866.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3400...

  9. 21 CFR 866.3340 - Klebsiella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Klebsiella spp. serological reagents. 866.3340 Section 866.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3340...

  10. 21 CFR 866.1620 - Antimicrobial susceptibility test disc.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antimicrobial susceptibility test disc. 866.1620 Section 866.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1620...

  11. 21 CFR 866.2660 - Microorganism differentiation and identification device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microorganism differentiation and identification device. 866.2660 Section 866.2660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology...

  12. 21 CFR 866.3410 - Proteus spp. (Weil-Felix) serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Proteus spp. (Weil-Felix) serological reagents. 866.3410 Section 866.3410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  13. 21 CFR 866.3020 - Adenovirus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Adenovirus serological reagents. 866.3020 Section 866.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3020...

  14. 21 CFR 866.3065 - Bordetella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bordetella spp. serological reagents. 866.3065 Section 866.3065 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3065...

  15. 21 CFR 866.4100 - Complement reagent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Complement reagent. 866.4100 Section 866.4100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents §...

  16. 21 CFR 866.3300 - Haemophilus spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Haemophilus spp. serological reagents. 866.3300 Section 866.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3300...

  17. 21 CFR 866.3460 - Rabiesvirus immuno-fluorescent reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rabiesvirus immuno-fluorescent reagents. 866.3460 Section 866.3460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3460...

  18. 21 CFR 866.2580 - Gas-generating device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas-generating device. 866.2580 Section 866.2580 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2580 Gas-generating...

  19. 21 CFR 866.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions §...

  20. 21 CFR 866.4700 - Automated fluorescence in situ hybridization (FISH) enumeration systems.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated fluorescence in situ hybridization (FISH) enumeration systems. 866.4700 Section 866.4700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES...

  1. 21 CFR 866.2440 - Automated medium dispensing and stacking device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated medium dispensing and stacking device. 866.2440 Section 866.2440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices §...

  2. 21 CFR 866.1645 - Fully automated short-term incubation cycle antimicrobial susceptibility system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fully automated short-term incubation cycle antimicrobial susceptibility system. 866.1645 Section 866.1645 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

  3. 21 CFR 866.2120 - Anaerobic chamber.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Anaerobic chamber. 866.2120 Section 866.2120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2120 Anaerobic chamber....

  4. 21 CFR 866.3085 - Brucella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Brucella spp. serological reagents. 866.3085 Section 866.3085 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3085 Brucella...

  5. 21 CFR 866.3402 - Plasmodium species antigen detection assays.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Plasmodium species antigen detection assays. 866.3402 Section 866.3402 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  6. 21 CFR 866.4900 - Support gel.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Support gel. 866.4900 Section 866.4900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents § 866.4900 Support gel....

  7. 21 CFR 866.3390 - Neisseria spp. direct serological test reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Neisseria spp. direct serological test reagents. 866.3390 Section 866.3390 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  8. 21 CFR 866.2600 - Wood's fluorescent lamp.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wood's fluorescent lamp. 866.2600 Section 866.2600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2600 Wood's...

  9. 21 CFR 866.4800 - Radial immunodiffusion plate.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radial immunodiffusion plate. 866.4800 Section 866.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents §...

  10. 21 CFR 866.3050 - Beta-glucan serological assays.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Beta-glucan serological assays. 866.3050 Section 866.3050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3050...

  11. 21 CFR 866.3125 - Citrobacter spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Citrobacter spp. serological reagents. 866.3125 Section 866.3125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3125...

  12. 21 CFR 866.3035 - Arizona spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Arizona spp. serological reagents. 866.3035 Section 866.3035 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3035 Arizona...

  13. 21 CFR 866.3010 - Acinetobacter calcoaceticus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Acinetobacter calcoaceticus serological reagents. 866.3010 Section 866.3010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  14. 21 CFR 866.3500 - Rickettsia serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rickettsia serological reagents. 866.3500 Section 866.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3500...

  15. 21 CFR 866.2540 - Microbiological incubator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microbiological incubator. 866.2540 Section 866.2540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2540...

  16. 21 CFR 866.3120 - Chlamydia serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chlamydia serological reagents. 866.3120 Section 866.3120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3120...

  17. 21 CFR 866.1640 - Antimicrobial susceptibility test powder.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antimicrobial susceptibility test powder. 866.1640 Section 866.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Diagnostic Devices § 866.1640...

  18. 21 CFR 866.3380 - Mumps virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mumps virus serological reagents. 866.3380 Section 866.3380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3380 Mumps...

  19. 21 CFR 866.2900 - Microbiological specimen collection and transport device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microbiological specimen collection and transport device. 866.2900 Section 866.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology...

  20. 21 CFR 866.2180 - Manual colony counter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual colony counter. 866.2180 Section 866.2180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2180 Manual colony...

  1. 21 CFR 866.4600 - Ouchterlony agar plate.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ouchterlony agar plate. 866.4600 Section 866.4600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents §...

  2. 21 CFR 866.3375 - Mycoplasma spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mycoplasma spp. serological reagents. 866.3375 Section 866.3375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3375...

  3. 21 CFR 866.3220 - Entamoeba histolytica serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Entamoeba histolytica serological reagents. 866.3220 Section 866.3220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  4. 21 CFR 868.1860 - Peak-flow meter for spirometry.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Peak-flow meter for spirometry. 868.1860 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1860 Peak-flow meter for spirometry. (a) Identification. A peak-flow meter for spirometry is a device used to measure a...

  5. 21 CFR 870.2880 - Ultrasonic transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... structures. This device includes phased arrays and two-dimensional scanning transducers. (b) Classification... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultrasonic transducer. 870.2880 Section 870.2880...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2880 Ultrasonic...

  6. 21 CFR 201.16 - Drugs; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs; Spanish-language version of certain...; Spanish-language version of certain required statements. An increasing number of medications restricted to... where Spanish is the predominant language. Such labeling is authorized under § 201.15(c). One...

  7. 21 CFR 876.5540 - Blood access device and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood access device and accessories. 876.5540... (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5540 Blood access device and accessories. (a) Identification. A blood access device and accessories is a device intended...

  8. 21 CFR 862.1675 - Blood specimen collection device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood specimen collection device. 862.1675 Section... Systems § 862.1675 Blood specimen collection device. (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to...

  9. 21 CFR 866.3660 - Shigella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shigella spp. serological reagents. 866.3660 Section 866.3660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3660 Shigella...

  10. 21 CFR 866.3600 - Schistosoma spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Schistosoma spp. serological reagents. 866.3600 Section 866.3600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3600...

  11. 21 CFR 866.3520 - Rubeola (measles) virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rubeola (measles) virus serological reagents. 866.3520 Section 866.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  12. 21 CFR 866.3820 - Treponema pallidum non-treponemal test reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Treponema pallidum non-treponemal test reagents. 866.3820 Section 866.3820 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  13. 21 CFR 866.3680 - Sporothrix schenckii serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Sporothrix schenckii serological reagents. 866.3680 Section 866.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  14. 21 CFR 866.3630 - Serratia spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Serratia spp. serological reagents. 866.3630 Section 866.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3630 Serratia...

  15. 21 CFR 866.3850 - Trichinella spiralis serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Trichinella spiralis serological reagents. 866.3850 Section 866.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents §...

  16. 21 CFR 866.3740 - Streptococcus spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Streptococcus spp. serological reagents. 866.3740 Section 866.3740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3740...

  17. 21 CFR 864.8540 - Red cell lysing reagent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Red cell lysing reagent. 864.8540 Section 864.8540...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8540 Red cell lysing reagent. (a) Identification. A red cell lysing reagent is a device used to lyse (destroy) red blood cells...

  18. 21 CFR 864.8150 - Calibrator for cell indices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Calibrator for cell indices. 864.8150 Section 864...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8150 Calibrator for cell indices. (a) Identification. A calibrator for cell indices is a device that approximates whole blood...

  19. 21 CFR 864.7100 - Red blood cell enzyme assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Red blood cell enzyme assay. 864.7100 Section 864...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7100 Red blood cell enzyme assay. (a) Identification. Red blood cell enzyme assay is a device used to measure the activity...

  20. 21 CFR 510.112 - Antibiotics used in veterinary medicine and for nonmedical purposes; required data.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Antibiotics used in veterinary medicine and for... DRUGS Specific Administrative Rulings and Decisions § 510.112 Antibiotics used in veterinary medicine... Medical and Nonmedical Uses of Antibiotics, was formed by the Food and Drug Administration to study,...

  1. 21 CFR 872.6200 - Base plate shellac.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Base plate shellac. 872.6200 Section 872.6200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6200 Base plate shellac. (a) Identification. Base...

  2. 21 CFR 868.2775 - Electrical peripheral nerve stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... a device used to apply an electrical current to a patient to test the level of pharmacological... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrical peripheral nerve stimulator. 868.2775... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2775 Electrical peripheral...

  3. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted...

  4. 21 CFR 872.6870 - Disposable fluoride tray.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Disposable fluoride tray. 872.6870 Section 872...) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6870 Disposable fluoride tray. (a) Identification. A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically...

  5. 21 CFR 886.1910 - Spectacle dissociation test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Spectacle dissociation test system. 886.1910... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1910 Spectacle dissociation test system. (a) Identification. A spectacle dissociation test system is an AC-powered or...

  6. 21 CFR 868.1640 - Helium gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Helium gas analyzer. 868.1640 Section 868.1640...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1640 Helium gas analyzer. (a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a...

  7. 21 CFR 872.4620 - Fiber optic dental light.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fiber optic dental light. 872.4620 Section 872...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4620 Fiber optic dental light. (a) Identification. A fiber optic dental light is a device that is a light, usually AC-powered, that consists of glass...

  8. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic bar reader. 886.5800 Section 886.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader....

  9. 21 CFR 872.4880 - Intraosseous fixation screw or wire.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraosseous fixation screw or wire. 872.4880... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4880 Intraosseous fixation screw or wire. (a) Identification. An intraosseous fixation screw or wire is a metal device intended to be...

  10. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraoral ligature and wire lock. 872.4600 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4600 Intraoral ligature and wire lock. (a) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured...

  11. 21 CFR 870.1330 - Catheter guide wire.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Catheter guide wire. 870.1330 Section 870.1330...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1330 Catheter guide wire. (a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside...

  12. 21 CFR 882.5910 - Dura substitute.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dura substitute. 882.5910 Section 882.5910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... surrounding the brain). (b) Classification. Class II (performance standards)....

  13. 21 CFR 882.4600 - Leukotome.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Leukotome. 882.4600 Section 882.4600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... device used to cut sections out of the brain. (b) Classification. Class I (general controls). The...

  14. 21 CFR 878.4010 - Tissue adhesive.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tissue adhesive. 878.4010 Section 878.4010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic...

  15. 21 CFR 882.5050 - Biofeedback device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Biofeedback device. 882.5050 Section 882.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... the status of one or more of a patient's physiological parameters (e.g., brain alpha wave...

  16. 21 CFR 882.1825 - Rheoencephalograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rheoencephalograph. 882.1825 Section 882.1825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... the brain) by electrical impedance methods with direct electrical connections to the scalp or...

  17. 21 CFR 882.1330 - Depth electrode.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Depth electrode. 882.1330 Section 882.1330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... signals at, subsurface levels of the brain. (b) Classification. Class II (performance standards)....

  18. 21 CFR 868.1700 - Nitrous oxide gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitrous oxide gas analyzer. 868.1700 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1700 Nitrous oxide gas analyzer. (a) Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous...

  19. 21 CFR 864.7425 - Carboxyhemoglobin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carboxyhemoglobin assay. 864.7425 Section 864.7425...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7425 Carboxyhemoglobin assay. (a) Identification. A carboxyhemoglobin assay is a device used to determine the...

  20. 21 CFR 870.2750 - Impedance phlebograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Impedance phlebograph. 870.2750 Section 870.2750...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2750 Impedance phlebograph. (a) Identification. An impedance phlebograph is a device used to provide a visual display of...

  1. 21 CFR 870.2770 - Impedance plethysmograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Impedance plethysmograph. 870.2770 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2770 Impedance plethysmograph. (a) Identification. An impedance plethysmograph is a device used to estimate peripheral...

  2. 21 CFR 874.1090 - Auditory impedance tester.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Auditory impedance tester. 874.1090 Section 874...) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Diagnostic Devices § 874.1090 Auditory impedance tester. (a) Identification. An auditory impedance tester is a device that is intended to change the air pressure in...

  3. 21 CFR 808.80 - New Jersey.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false New Jersey. 808.80 Section 808.80 Food and Drugs... and Local Exemptions § 808.80 New Jersey. (a) The following New Jersey medical device requirements are... them from preemption under section 521(b) of the act: (1) New Jersey Statutes Annotated, section...

  4. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  5. 21 CFR 880.2720 - Patient scale.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Patient scale. 880.2720 Section 880.2720 Food and... Patient scale. (a) Identification. A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale. This generic device includes...

  6. 21 CFR 880.6375 - Patient lubricant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Patient lubricant. 880.6375 Section 880.6375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... § 880.6375 Patient lubricant. (a) Identification. A patient lubricant is a device intended for...

  7. 21 CFR 880.5110 - Hydraulic adjustable hospital bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hydraulic adjustable hospital bed. 880.5110... Therapeutic Devices § 880.5110 Hydraulic adjustable hospital bed. (a) Identification. A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic...

  8. 21 CFR 876.5520 - Urethral dilator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Urethral dilator. 876.5520 Section 876.5520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... flexibilities. The device may include a mechanism to expand the portion of the device in the urethra...

  9. 21 CFR 892.1410 - Nuclear electrocardiograph synchronizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear electrocardiograph synchronizer. 892.1410... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1410 Nuclear electrocardiograph synchronizer. (a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use...

  10. 21 CFR 892.1370 - Nuclear anthropomorphic phantom.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear anthropomorphic phantom. 892.1370 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1370 Nuclear anthropomorphic phantom. (a) Identification. A nuclear anthropomorphic phantom is a human tissue facsimile that contains...

  11. 21 CFR 892.1130 - Nuclear whole body counter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear whole body counter. 892.1130 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1130 Nuclear whole body counter. (a) Identification. A nuclear whole body counter is a device intended to measure the amount of radionuclides in...

  12. 21 CFR 892.1400 - Nuclear sealed calibration source.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source. (a) Identification. A nuclear sealed calibration source is a device that consists of an...

  13. 21 CFR 892.1330 - Nuclear whole body scanner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear whole body scanner. 892.1330 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1330 Nuclear whole body scanner. (a) Identification. A nuclear whole body scanner is a device intended to measure and image the distribution...

  14. 21 CFR 892.1350 - Nuclear scanning bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear scanning bed. 892.1350 Section 892.1350...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1350 Nuclear scanning bed. (a) Identification. A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear...

  15. 21 CFR 892.1320 - Nuclear uptake probe.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear uptake probe. 892.1320 Section 892.1320...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1320 Nuclear uptake probe. (a) Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by...

  16. 21 CFR 892.1300 - Nuclear rectilinear scanner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear rectilinear scanner. 892.1300 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1300 Nuclear rectilinear scanner. (a) Identification. A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides...

  17. 21 CFR 882.4360 - Electric cranial drill motor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electric cranial drill motor. 882.4360 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4360 Electric cranial drill motor. (a) Identification. An electric cranial drill motor is an electrically operated power source...

  18. 21 CFR 882.4325 - Cranial drill handpiece (brace).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cranial drill handpiece (brace). 882.4325 Section... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4325 Cranial drill handpiece (brace). (a) Identification. A cranial drill handpiece (brace) is a hand holder, which is...

  19. 21 CFR 872.4130 - Intraoral dental drill.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraoral dental drill. 872.4130 Section 872.4130...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4130 Intraoral dental drill. (a) Identification. An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes...

  20. 21 CFR 886.1655 - Ophthalmic Fresnel prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings...

  1. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld...

  2. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually...

  3. 21 CFR 886.5810 - Ophthalmic prism reader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine...

  4. 21 CFR 870.3945 - Prosthetic heart valve sizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic heart valve sizer. 870.3945 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3945 Prosthetic heart valve sizer. (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of...

  5. 21 CFR 870.3925 - Replacement heart valve.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of...

  6. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for...

  7. 21 CFR 886.1425 - Lens measuring instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lens measuring instrument. 886.1425 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1425 Lens measuring instrument. (a) Identification. A lens measuring instrument is an AC-powered device intended to measure the power of...

  8. 21 CFR 886.4300 - Intraocular lens guide.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraocular lens guide. 886.4300 Section 886.4300...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to...

  9. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  10. 21 CFR 886.1400 - Maddox lens.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Maddox lens. 886.1400 Section 886.1400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1400 Maddox lens. (a) Identification. A Maddox lens is a...

  11. 21 CFR 886.1390 - Flexible diagnostic Fresnel lens.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Flexible diagnostic Fresnel lens. 886.1390 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1390 Flexible diagnostic Fresnel lens. (a) Identification. A flexible diagnostic Fresnel lens is a device that is a very thin lens which...

  12. 21 CFR 886.1380 - Diagnostic condensing lens.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic condensing lens. 886.1380 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a...

  13. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of...

  14. 21 CFR 886.1395 - Diagnostic Hruby fundus lens.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic Hruby fundus lens. 886.1395 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1395 Diagnostic Hruby fundus lens. (a) Identification. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in...

  15. 21 CFR 809.40 - Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing. 809.40 Section 809.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES...

  16. 21 CFR 860.3 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Definitions. 860.3 Section 860.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES...) Act means the Federal Food, Drug, and Cosmetic Act. (b) Commissioner means the Commissioner of...

  17. 21 CFR 870.2600 - Signal isolation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Signal isolation system. 870.2600 Section 870.2600...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2600 Signal isolation system. (a) Identification. A signal isolation system is a device that electrically isolates the...

  18. 21 CFR 26.44 - Transmission of product evaluation reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Transmission of product evaluation reports. 26.44 Section 26.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY...

  19. 21 CFR 26.38 - Other transition period activities.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Other transition period activities. 26.38 Section 26.38 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY...

  20. 21 CFR 26.48 - Harmonization.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Harmonization. 26.48 Section 26.48 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND...

  1. 21 CFR 26.49 - Regulatory cooperation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Regulatory cooperation. 26.49 Section 26.49 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT...

  2. 21 CFR 26.45 - Monitoring continued equivalence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Monitoring continued equivalence. 26.45 Section 26.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY...

  3. 21 CFR Appendices C-F to Subpart B... - [Reserved

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false C Appendices C-F to Subpart B of Part 26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT...

  4. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Alert system and exchange of postmarket vigilance reports. 26.50 Section 26.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  5. 21 CFR 26.33 - Product coverage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Product coverage. 26.33 Section 26.33 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT...

  6. 21 CFR 26.43 - Transmission of quality system evaluation reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Transmission of quality system evaluation reports. 26.43 Section 26.43 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  7. 21 CFR 888.3010 - Bone fixation cerclage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone fixation cerclage. 888.3010 Section 888.3010...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3010 Bone fixation cerclage. (a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such...

  8. 21 CFR 872.4120 - Bone cutting instrument and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone cutting instrument and accessories. 872.4120... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4120 Bone cutting instrument and accessories. (a) Identification. A bone cutting instrument and accessories is a metal device intended for...

  9. 21 CFR 874.4800 - Bone particle collector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone particle collector. 874.4800 Section 874.4800...) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4800 Bone particle collector. (a) Identification. A bone particle collector is a filtering device intended to be inserted into a suction...

  10. 21 CFR 872.3930 - Bone grafting material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone grafting material. 872.3930 Section 872.3930...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3930 Bone grafting material. (a) Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic...

  11. 21 CFR 892.1170 - Bone densitometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone densitometer. 892.1170 Section 892.1170 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1170 Bone densitometer. (a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray...

  12. 21 CFR 866.5860 - Total spinal fluid immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... diagnosis of multiple sclerosis and other diseases of the nervous system. (b) Classification. Class I... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Total spinal fluid immuno-logical test system. 866... SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems §...

  13. 21 CFR 862.3100 - Amphetamine test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Amphetamine test system. 862.3100 Section 862.3100...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems §...

  14. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic...

  15. 21 CFR 888.3000 - Bone cap.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone cap. 888.3000 Section 888.3000 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3000 Bone cap. (a) Identification. A bone cap is a...

  16. 21 CFR 888.4220 - Cement monomer vapor evacuator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cement monomer vapor evacuator. 888.4220 Section... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Surgical Devices § 888.4220 Cement monomer vapor evacuator. (a) Identification. A cement monomer vapor evacuator is a device intended for use during surgery to contain or...

  17. 21 CFR 888.4210 - Cement mixer for clinical use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cement mixer for clinical use. 888.4210 Section... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Surgical Devices § 888.4210 Cement mixer for clinical use. (a) Identification. A cement mixer for clinical use is a device consisting of a container intended for use in...

  18. 21 CFR 876.5665 - Water purification system for hemodialysis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Water purification system for hemodialysis. 876... SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876.5665 Water purification system for hemodialysis. (a) Identification. A water purification system for hemodialysis is...

  19. 21 CFR 820.5 - Quality system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Quality system. 820.5 Section 820.5 Food and Drugs... QUALITY SYSTEM REGULATION General Provisions § 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or...

  20. 21 CFR 820.186 - Quality system record.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Quality system record. 820.186 Section 820.186...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.186 Quality system record. Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures...

  1. 21 CFR 868.2385 - Nitrogen dioxide analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitrogen dioxide analyzer. 868.2385 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2385 Nitrogen dioxide analyzer. (a) Identification. The nitrogen dioxide analyzer is a device intended to measure the concentration of...

  2. 21 CFR 868.1690 - Nitrogen gas analyzer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen...

  3. 21 CFR 872.4630 - Dental operating light.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental operating light. 872.4630 Section 872.4630...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4630 Dental operating light. (a) Identification. A dental operating light, including the surgical headlight, is an AC-powered device intended to...

  4. 21 CFR 876.4020 - Fiberoptic light ureteral catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fiberoptic light ureteral catheter. 876.4020... (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Surgical Devices § 876.4020 Fiberoptic light ureteral catheter. (a) Identification. A fiberoptic light ureteral catheter is a device that consists of...

  5. 21 CFR 866.3330 - Influenza virus serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Influenza virus serological reagents. 866.3330... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3330 Influenza virus serological reagents. (a) Identification. Influenza virus serological reagents are devices...

  6. 21 CFR 892.1380 - Nuclear flood source phantom.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear flood source phantom. 892.1380 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1380 Nuclear flood source phantom. (a) Identification. A nuclear flood source phantom is a device that consists of a radiolucent container filled with...

  7. 21 CFR 888.3570 - Knee joint femoral (hemi-knee) metallic uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femoral (hemi-knee) metallic uncemented... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis. (a) Identification. A knee joint femoral...

  8. 21 CFR 870.4875 - Intraluminal artery stripper.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraluminal artery stripper. 870.4875 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4875 Intraluminal artery stripper. (a) Identification. An intraluminal artery stripper is a device used to perform an...

  9. 21 CFR 868.5250 - Breathing circuit circulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing circuit circulator. 868.5250 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5250 Breathing circuit circulator. (a) Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing...

  10. 21 CFR 868.5270 - Breathing system heater.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing system heater. 868.5270 Section 868.5270...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5270 Breathing system heater. (a) Identification. A breathing system heater is a device that is intended to warm breathing gases before they...

  11. 21 CFR 868.5620 - Breathing mouthpiece.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing mouthpiece. 868.5620 Section 868.5620...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5620 Breathing mouthpiece. (a) Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and...

  12. 21 CFR 868.2375 - Breathing frequency monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing frequency monitor. 868.2375 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2375 Breathing frequency monitor. (a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a...

  13. 21 CFR 868.5260 - Breathing circuit bacterial filter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing circuit bacterial filter. 868.5260... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5260 Breathing circuit bacterial filter. (a) Identification. A breathing circuit bacterial filter is a device that is intended to...

  14. 21 CFR 868.5330 - Breathing gas mixer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Breathing gas mixer. 868.5330 Section 868.5330...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5330 Breathing gas mixer. (a) Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory...

  15. 21 CFR 882.5970 - Cranial orthosis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cranial orthosis. 882.5970 Section 882.5970 Food... DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5970 Cranial orthosis. (a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure...

  16. 21 CFR 886.5870 - Low-vision telescope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Low-vision telescope. 886.5870 Section 886.5870...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5870 Low-vision telescope. (a) Identification. A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended...

  17. 20 CFR 404.1525 - Listing of Impairments in appendix 1.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Listing of Impairments in appendix 1. 404.1525 Section 404.1525 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical Considerations § 404.1525...

  18. 20 CFR 404.1538 - What we mean by approved institutions or facilities.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false What we mean by approved institutions or facilities. 404.1538 Section 404.1538 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical...

  19. 20 CFR 404.1530 - Need to follow prescribed treatment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Need to follow prescribed treatment. 404.1530 Section 404.1530 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical Considerations § 404.1530 Need...

  20. 20 CFR 404.1539 - How we consider whether treatment is available.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false How we consider whether treatment is available. 404.1539 Section 404.1539 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical...

  1. 20 CFR 404.1527 - Evaluating opinion evidence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Evaluating opinion evidence. 404.1527 Section 404.1527 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical Considerations § 404.1527 Evaluating...

  2. 20 CFR 404.1540 - Evaluating compliance with the treatment requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Evaluating compliance with the treatment requirements. 404.1540 Section 404.1540 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical...

  3. 20 CFR 404.1537 - What we mean by appropriate treatment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false What we mean by appropriate treatment. 404.1537 Section 404.1537 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness Medical Considerations § 404.1537 What...

  4. 21 CFR 876.1400 - Stomach pH electrode.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Stomach pH electrode. 876.1400 Section 876.1400...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Diagnostic Devices § 876.1400 Stomach pH electrode. (a) Identification. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH...

  5. 21 CFR 888.3080 - Intervertebral body fusion device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intervertebral body fusion device. 888.3080 Section 888.3080 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3080 Intervertebral body...

  6. 21 CFR 320.23 - Basis for measuring in vivo bioavailability or demonstrating bioequivalence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is... attainment of effective body drug concentrations on chronic use, and are considered medically insignificant... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Basis for measuring in vivo bioavailability...

  7. 21 CFR 890.5300 - Ultrasonic diathermy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultrasonic diathermy. 890.5300 Section 890.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... medical conditions is a device that applies to specific areas of the body ultrasonic energy at a...

  8. 21 CFR 890.5275 - Microwave diathermy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microwave diathermy. 890.5275 Section 890.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... medical conditions is a device that applies to specific areas of the body electromagnetic energy in...

  9. 21 CFR 890.3610 - Rigid pneumatic structure orthosis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rigid pneumatic structure orthosis. 890.3610 Section 890.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... for medical purposes to provide whole body support by means of a pressurized suit to help...

  10. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and...

  11. 21 CFR 866.3550 - Salmonella spp. serological reagents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Salmonella spp. serological reagents. 866.3550... (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Serological Reagents § 866.3550 Salmonella spp. serological reagents. (a) Identification. Salmonella spp. serological reagents are devices...

  12. 21 CFR 880.5550 - Alternating pressure air flotation mattress.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alternating pressure air flotation mattress. 880... Personal Use Therapeutic Devices § 880.5550 Alternating pressure air flotation mattress. (a) Identification. An alternating pressure air flotation mattress is a device intended for medical purposes...

  13. 21 CFR 884.3575 - Vaginal pessary.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vaginal pessary. 884.3575 Section 884.3575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... Vaginal pessary. (a) Identification. A vaginal pessary is a removable structure placed in the vagina...

  14. 22 CFR 192.30 - Eligibility for benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Eligibility for benefits. 192.30 Section 192.30 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.30 Eligibility for benefits. A person designated as a captive or...

  15. 22 CFR 192.33 - Dispute.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Dispute. 192.33 Section 192.33 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.33 Dispute. Any dispute between the Office and eligible persons concerning whether...

  16. 22 CFR 192.31 - Applicable benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Applicable benefits. 192.31 Section 192.31 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.31 Applicable benefits. A person eligible for benefits under this...

  17. 22 CFR 192.32 - Administration of benefits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Administration of benefits. 192.32 Section 192.32 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive Situations § 192.32 Administration of benefits. (a)(1) A person eligible due...

  18. 21 CFR 890.5410 - Powered finger exerciser.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered finger exerciser. 890.5410 Section 890.5410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5410 Powered...

  19. 21 CFR 890.5720 - Water circulating hot or cold pack.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Water circulating hot or cold pack. 890.5720 Section 890.5720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5720...

  20. 21 CFR 890.5575 - Powered external limb overload warning device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered external limb overload warning device. 890.5575 Section 890.5575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  1. 21 CFR 890.5100 - Immersion hydrobath.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Immersion hydrobath. 890.5100 Section 890.5100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5100...

  2. 21 CFR 890.3075 - Cane.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cane. 890.3075 Section 890.3075 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3075 Cane. (a) Identification. A...

  3. 21 CFR 890.3825 - Mechanical walker.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical walker. 890.3825 Section 890.3825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3825 Mechanical walker....

  4. 21 CFR 890.3860 - Powered wheelchair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered wheelchair. 890.3860 Section 890.3860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3860 Powered wheelchair....

  5. 21 CFR 890.5740 - Powered heating pad.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered heating pad. 890.5740 Section 890.5740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5740 Powered...

  6. 21 CFR 890.3880 - Special grade wheelchair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Special grade wheelchair. 890.3880 Section 890.3880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3880 Special...

  7. 21 CFR 890.3420 - External limb prosthetic component.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External limb prosthetic component. 890.3420 Section 890.3420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  8. 21 CFR 890.5850 - Powered muscle stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered muscle stimulator. 890.5850 Section 890.5850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5850 Powered...

  9. 21 CFR 890.3710 - Powered communication system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered communication system. 890.3710 Section 890.3710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3710...

  10. 21 CFR 890.1925 - Isokinetic testing and evaluation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Isokinetic testing and evaluation system. 890.1925 Section 890.1925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices §...

  11. 21 CFR 890.1175 - Electrode cable.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrode cable. 890.1175 Section 890.1175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1175 Electrode cable....

  12. 21 CFR 890.1375 - Diagnostic electromyograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic electromyograph. 890.1375 Section 890.1375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1375...

  13. 21 CFR 890.5360 - Measuring exercise equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Measuring exercise equipment. 890.5360 Section 890.5360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5360...

  14. 21 CFR 890.3725 - Powered environmental control system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered environmental control system. 890.3725 Section 890.3725 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3725...

  15. 21 CFR 890.3150 - Crutch.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Crutch. 890.3150 Section 890.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3150 Crutch. (a) Identification....

  16. 21 CFR 890.5765 - Presssure-applying device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Presssure-applying device. 890.5765 Section 890.5765 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5765...

  17. 21 CFR 890.3750 - Mechanical table.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical table. 890.3750 Section 890.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3750 Mechanical table....

  18. 21 CFR 890.3475 - Limb orthosis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limb orthosis. 890.3475 Section 890.3475 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3475 Limb orthosis. (a)...

  19. 21 CFR 890.3690 - Powered wheeled stretcher.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered wheeled stretcher. 890.3690 Section 890.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3690 Powered...

  20. 21 CFR 890.5290 - Shortwave diathermy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shortwave diathermy. 890.5290 Section 890.5290 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5290...

  1. 21 CFR 890.5170 - Powered flotation therapy bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered flotation therapy bed. 890.5170 Section 890.5170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  2. 21 CFR 890.5880 - Multi-function physical therapy table.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Multi-function physical therapy table. 890.5880 Section 890.5880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5880...

  3. 21 CFR 890.3800 - Motorized three-wheeled vehicle.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Motorized three-wheeled vehicle. 890.3800 Section 890.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  4. 21 CFR 890.3930 - Wheelchair elevator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wheelchair elevator. 890.3930 Section 890.3930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3930...

  5. 21 CFR 890.5225 - Powered patient rotation bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered patient rotation bed. 890.5225 Section 890.5225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5225 Powered...

  6. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  7. 21 CFR 890.3025 - Prosthetic and orthotic accessory.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic and orthotic accessory. 890.3025 Section 890.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  8. 21 CFR 890.5660 - Therapeutic massager.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Therapeutic massager. 890.5660 Section 890.5660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5660...

  9. 21 CFR 890.3700 - Nonpowered communication system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonpowered communication system. 890.3700 Section 890.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  10. 21 CFR 890.3175 - Flotation cushion.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Flotation cushion. 890.3175 Section 890.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3175 Flotation cushion....

  11. 21 CFR 890.1225 - Chronaximeter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chronaximeter. 890.1225 Section 890.1225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1225 Chronaximeter. (a)...

  12. 21 CFR 890.5150 - Powered patient transport.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered patient transport. 890.5150 Section 890.5150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5150 Powered...

  13. 21 CFR 890.5050 - Daily activity assist device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily...

  14. 21 CFR 890.1385 - Diagnostic electromyograph needle electrode.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic electromyograph needle electrode. 890.1385 Section 890.1385 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices §...

  15. 21 CFR 890.5250 - Moist steam cabinet.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Moist steam cabinet. 890.5250 Section 890.5250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5250 Moist...

  16. 21 CFR 890.3665 - Congenital hip dislocation abduction splint.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Congenital hip dislocation abduction splint. 890.3665 Section 890.3665 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  17. 21 CFR 890.3910 - Wheelchair accessory.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wheelchair accessory. 890.3910 Section 890.3910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3910...

  18. 21 CFR 890.5180 - Manual patient rotation bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual patient rotation bed. 890.5180 Section 890.5180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5180 Manual...

  19. 21 CFR 890.3890 - Stair-climbing wheelchair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Stair-climbing wheelchair. 890.3890 Section 890.3890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3890...

  20. 21 CFR 890.5900 - Power traction equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Power traction equipment. 890.5900 Section 890.5900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5900 Power...

  1. 21 CFR 890.1850 - Diagnostic muscle stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic muscle stimulator. 890.1850 Section 890.1850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1850...

  2. 21 CFR 890.3790 - Cane, crutch, and walker tips and pads.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cane, crutch, and walker tips and pads. 890.3790 Section 890.3790 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3790...

  3. 21 CFR 890.3640 - Arm sling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Arm sling. 890.3640 Section 890.3640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3640 Arm sling. (a) Identification....

  4. 21 CFR 890.5160 - Air-fluidized bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Air-fluidized bed. 890.5160 Section 890.5160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5160 Air-fluidized bed....

  5. 21 CFR 890.5125 - Nonpowered sitz bath.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonpowered sitz bath. 890.5125 Section 890.5125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5125 Nonpowered...

  6. 21 CFR 890.5730 - Moist heat pack.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Moist heat pack. 890.5730 Section 890.5730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5730 Moist heat pack....

  7. 21 CFR 890.5500 - Infrared lamp.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Infrared lamp. 890.5500 Section 890.5500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5500 Infrared lamp....

  8. 21 CFR 890.3675 - Denis Brown splint.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Denis Brown splint. 890.3675 Section 890.3675 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3675 Denis Brown splint....

  9. 21 CFR 890.3100 - Mechanical chair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical chair. 890.3100 Section 890.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3100 Mechanical chair....

  10. 21 CFR 890.3920 - Wheelchair component.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wheelchair component. 890.3920 Section 890.3920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3920...

  11. 21 CFR 890.5700 - Cold pack.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cold pack. 890.5700 Section 890.5700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5700 Cold pack. (a) Identification....

  12. 21 CFR 890.5925 - Traction accessory.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Traction accessory. 890.5925 Section 890.5925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5925 Traction accessory....

  13. 21 CFR 890.3900 - Standup wheelchair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Standup wheelchair. 890.3900 Section 890.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3900 Standup wheelchair....

  14. 21 CFR 890.3850 - Mechanical wheelchair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical wheelchair. 890.3850 Section 890.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3850...

  15. 21 CFR 890.1575 - Force-measuring platform.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Force-measuring platform. 890.1575 Section 890.1575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Diagnostic Devices § 890.1575...

  16. 21 CFR 890.5940 - Chilling unit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chilling unit. 890.5940 Section 890.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5940 Chilling unit....

  17. 21 CFR 890.3110 - Electric positioning chair.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electric positioning chair. 890.3110 Section 890.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3110...

  18. 21 CFR 890.3410 - External limb orthotic component.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External limb orthotic component. 890.3410 Section 890.3410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  19. 21 CFR 890.3490 - Truncal orthosis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Truncal orthosis. 890.3490 Section 890.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3490 Truncal orthosis....

  20. 21 CFR 890.5110 - Paraffin bath.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Paraffin bath. 890.5110 Section 890.5110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5110 Paraffin bath....

  1. 21 CFR 890.3760 - Powered table.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered table. 890.3760 Section 890.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3760 Powered table. (a)...

  2. 21 CFR 890.5710 - Hot or cold disposable pack.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hot or cold disposable pack. 890.5710 Section 890.5710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5710 Hot or...

  3. 21 CFR 890.5370 - Nonmeasuring exercise equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonmeasuring exercise equipment. 890.5370 Section 890.5370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  4. 21 CFR 890.3520 - Plinth.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Plinth. 890.3520 Section 890.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3520 Plinth. (a) Identification....

  5. 21 CFR 890.5350 - Exercise component.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Exercise component. 890.5350 Section 890.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5350 Exercise component....

  6. 21 CFR 890.5380 - Powered exercise equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered exercise equipment. 890.5380 Section 890.5380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5380...

  7. 21 CFR 890.5650 - Powered inflatable tube massager.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered inflatable tube massager. 890.5650 Section 890.5650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  8. 21 CFR 872.6350 - Ultraviolet detector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultraviolet detector. 872.6350 Section 872.6350...) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6350 Ultraviolet detector. (a) Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is...

  9. 21 CFR 872.6070 - Ultraviolet activator for polymerization.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ultraviolet activator for polymerization. 872.6070... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6070 Ultraviolet activator for polymerization. (a) Identification. An ultraviolet activator for polymerization is a device that...

  10. 21 CFR 892.1000 - Magnetic resonance diagnostic device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Magnetic resonance diagnostic device. 892.1000... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1000 Magnetic resonance...

  11. 21 CFR 820.250 - Statistical techniques.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Statistical techniques. 820.250 Section 820.250...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Statistical Techniques § 820.250 Statistical techniques. (a... statistical techniques required for establishing, controlling, and verifying the acceptability of...

  12. 21 CFR 369.9 - General warnings re accidental ingestion by children.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false General warnings re accidental ingestion by children. 369.9 Section 369.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... this and all medicines out of children's reach. In case of overdose, get medical help or contact...

  13. 21 CFR 872.3110 - Dental amalgam capsule.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental amalgam capsule. 872.3110 Section 872.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3110 Dental amalgam capsule. (a) Identification....

  14. 21 CFR 872.3300 - Hydrophilic resin coating for dentures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hydrophilic resin coating for dentures. 872.3300 Section 872.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3300 Hydrophilic resin coating...

  15. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  16. 21 CFR 872.3130 - Preformed anchor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Preformed anchor. 872.3130 Section 872.3130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3130 Preformed anchor. (a) Identification. A...

  17. 21 CFR 870.3300 - Vascular embolization device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vascular embolization device. 870.3300 Section 870.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3300 Vascular...

  18. 21 CFR 870.3850 - Carotid sinus nerve stimulator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Carotid sinus nerve stimulator. 870.3850 Section 870.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3850 Carotid...

  19. 21 CFR 870.3250 - Vascular clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vascular clip. 870.3250 Section 870.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3250 Vascular clip. (a) Identification. A...

  20. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false OTC denture repair kit. 872.3570 Section 872.3570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3570 OTC denture repair kit. (a)...

  1. 21 CFR 870.3260 - Vena cava clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vena cava clip. 870.3260 Section 870.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3260 Vena cava clip. (a) Identification. A...

  2. 21 CFR 872.3770 - Temporary crown and bridge resin.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Temporary crown and bridge resin. 872.3770 Section 872.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3770 Temporary crown and bridge resin....

  3. 21 CFR 872.3540 - OTC denture cushion or pad.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false OTC denture cushion or pad. 872.3540 Section 872.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3540 OTC denture cushion or pad....

  4. 21 CFR 870.3460 - Endovascular Suturing System.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endovascular Suturing System. 870.3460 Section 870.3460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular...

  5. 21 CFR 872.3560 - OTC denture reliner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false OTC denture reliner. 872.3560 Section 872.3560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3560 OTC denture reliner. (a) Identification....

  6. 21 CFR 872.3760 - Denture relining, repairing, or rebasing resin.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Denture relining, repairing, or rebasing resin. 872.3760 Section 872.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3760 Denture...

  7. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  8. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  9. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Testicular prosthesis. 876.3750 Section 876.3750...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled...

  10. 21 CFR 861.36 - Effective dates.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates. 861.36 Section 861.36 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT Procedures for Performance Standards Development...

  11. 21 CFR 861.1 - Purpose and scope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Purpose and scope. 861.1 Section 861.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT General § 861.1 Purpose and scope. (a) This part...

  12. 21 CFR 861.5 - Statement of policy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Statement of policy. 861.5 Section 861.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT General § 861.5 Statement of policy. In carrying out...

  13. 21 CFR 861.20 - Summary of standards development process.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Summary of standards development process. 861.20 Section 861.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT Procedures for...

  14. 21 CFR 861.24 - Existing standard as a proposed standard.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Existing standard as a proposed standard. 861.24 Section 861.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT Procedures for...

  15. 21 CFR 861.7 - Contents of standards.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Contents of standards. 861.7 Section 861.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT General § 861.7 Contents of standards....

  16. 21 CFR 864.9125 - Vacuum-assisted blood collection system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vacuum-assisted blood collection system. 864.9125... Blood and Blood Products § 864.9125 Vacuum-assisted blood collection system. (a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum...

  17. 21 CFR 864.9185 - Blood grouping view box.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood grouping view box. 864.9185 Section 864.9185...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9185 Blood grouping view box. (a) Identification. A blood grouping view...

  18. 21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood...

  19. 21 CFR 868.1100 - Arterial blood sampling kit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Arterial blood sampling kit. 868.1100 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1100 Arterial blood sampling kit. (a) Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood...

  20. 21 CFR 872.3820 - Root canal filling resin.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Root canal filling resin. 872.3820 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3820 Root canal filling resin. (a) Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate,...

  1. 21 CFR 862.1430 - 17-Ketosteroids test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false 17-Ketosteroids test system. 862.1430 Section 862...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.1430 17-Ketosteroids test system. (a) Identification. A 17-ketosteroids test system is a...

  2. 21 CFR 862.1705 - Triglyceride test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Triglyceride test system. 862.1705 Section 862...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.1705 Triglyceride test system. (a) Identification. A triglyceride test system is a device intended...

  3. 21 CFR 862.1400 - Hydroxyproline test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hydroxyproline test system. 862.1400 Section 862...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.1400 Hydroxyproline test system. (a) Identification. A hydroxyproline test system is a device...

  4. 21 CFR 862.1540 - Osmolality test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Osmolality test system. 862.1540 Section 862.1540...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.1540 Osmolality test system. (a) Identification. An osmolality test system is a device intended...

  5. 21 CFR 882.5500 - Lesion temperature monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lesion temperature monitor. 882.5500 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5500 Lesion temperature monitor. (a) Identification. A lesion temperature monitor is a device used to monitor the...

  6. 21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic contact lens radius measuring device... SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1430 Ophthalmic contact lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device...

  7. 21 CFR 820.140 - Handling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Handling. 820.140 Section 820.140 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Handling, Storage, Distribution, and Installation § 820.140 Handling....

  8. 21 CFR 820.150 - Storage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Storage. 820.150 Section 820.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Handling, Storage, Distribution, and Installation § 820.150 Storage. (a)...

  9. 21 CFR 880.6990 - Infusion stand.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Infusion stand. 880.6990 Section 880.6990 Food and....6990 Infusion stand. (a) Identification. The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices. (b) Classification....

  10. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  11. 21 CFR 864.7375 - Glutathione reductase assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Glutathione reductase assay. 864.7375 Section 864.7375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7375...

  12. 21 CFR 864.5700 - Automated platelet aggregation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated platelet aggregation system. 864.5700 Section 864.5700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  13. 21 CFR 864.7060 - Antithrombin III assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antithrombin III assay. 864.7060 Section 864.7060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7060 Antithrombin...

  14. 21 CFR 864.6400 - Hematocrit measuring device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hematocrit measuring device. 864.6400 Section 864.6400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6400 Hematocrit...

  15. 21 CFR 864.7275 - Euglobulin lysis time tests.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Euglobulin lysis time tests. 864.7275 Section 864.7275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7275 Euglobulin...

  16. 21 CFR 864.8950 - Russell viper venom reagent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Russell viper venom reagent. 864.8950 Section 864.8950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8950 Russell viper...

  17. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Osmotic fragility test. 864.6600 Section 864.6600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6600 Osmotic...

  18. 21 CFR 864.3250 - Specimen transport and storage container.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Specimen transport and storage container. 864.3250 Section 864.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  19. 21 CFR 864.5425 - Multipurpose system for in vitro coagulation studies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Multipurpose system for in vitro coagulation studies. 864.5425 Section 864.5425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and...

  20. 21 CFR 864.5600 - Automated hematocrit instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated hematocrit instrument. 864.5600 Section 864.5600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  1. 21 CFR 864.3010 - Tissue processing equipment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tissue processing equipment. 864.3010 Section 864.3010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  2. 21 CFR 864.5850 - Automated slide spinner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated slide spinner. 864.5850 Section 864.5850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices §...

  3. 21 CFR 864.6650 - Platelet adhesion test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Platelet adhesion test. 864.6650 Section 864.6650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6650 Platelet...

  4. 21 CFR 864.7720 - Prothrombin consumption test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prothrombin consumption test. 864.7720 Section 864.7720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7720...

  5. 21 CFR 864.8175 - Calibrator for platelet counting.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Calibrator for platelet counting. 864.8175 Section 864.8175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8175 Calibrator...

  6. 21 CFR 864.7675 - Leukocyte peroxidase test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Leukocyte peroxidase test. 864.7675 Section 864.7675 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7675...

  7. 21 CFR 864.3875 - Automated tissue processor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated tissue processor. 864.3875 Section 864.3875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  8. 21 CFR 864.3300 - Cytocentrifuge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cytocentrifuge. 864.3300 Section 864.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3300 Cytocentrifuge....

  9. 21 CFR 864.6675 - Platelet aggregometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Platelet aggregometer. 864.6675 Section 864.6675 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6675...

  10. 21 CFR 864.7875 - Thrombin time test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thrombin time test. 864.7875 Section 864.7875 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7875 Thrombin time test....

  11. 21 CFR 864.7525 - Heparin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Heparin assay. 864.7525 Section 864.7525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7525 Heparin assay. (a) Identification....

  12. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Erythrocyte sedimentation rate test. 864.6700 Section 864.6700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6700...

  13. 21 CFR 864.6100 - Bleeding time device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bleeding time device. 864.6100 Section 864.6100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6100 Bleeding time...

  14. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3...

  15. 21 CFR 864.7900 - Thromboplastin generation test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Thromboplastin generation test. 864.7900 Section 864.7900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages §...

  16. 21 CFR 864.7695 - Platelet factor 4 radioimmunoassay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Platelet factor 4 radioimmunoassay. 864.7695 Section 864.7695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7695...

  17. 21 CFR 864.5350 - Microsedimentation centrifuge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microsedimentation centrifuge. 864.5350 Section 864.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  18. 21 CFR 864.3400 - Device for sealing microsections.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device for sealing microsections. 864.3400 Section 864.3400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories §...

  19. 21 CFR 864.5400 - Coagulation instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Coagulation instrument. 864.5400 Section 864.5400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices §...

  20. 21 CFR 864.7925 - Partial thromboplastin time tests.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Partial thromboplastin time tests. 864.7925 Section 864.7925 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7925...

  1. 21 CFR 864.5800 - Automated sedimentation rate device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated sedimentation rate device. 864.5800 Section 864.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology...

  2. 21 CFR 864.7490 - Sulfhemoglobin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Sulfhemoglobin assay. 864.7490 Section 864.7490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7490...

  3. 21 CFR 864.7250 - Erythropoietin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Erythropoietin assay. 864.7250 Section 864.7250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Kits and Packages § 864.7250...

  4. 20 CFR 30.508 - What is beryllium sensitivity monitoring?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false What is beryllium sensitivity monitoring? 30... and Offsets; Overpayments Payment of Claims and Offset for Certain Payments § 30.508 What is beryllium sensitivity monitoring? Beryllium sensitivity monitoring shall consist of medical examinations to confirm...

  5. 21 CFR 868.5860 - Pressure tubing and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pressure tubing and accessories. 868.5860 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5860 Pressure tubing and accessories. (a) Identification. Pressure tubing and accessories are flexible or rigid devices intended...

  6. 21 CFR 890.1600 - Intermittent pressure measurement system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intermittent pressure measurement system. 890.1600... Intermittent pressure measurement system. (a) Identification. An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the...

  7. 21 CFR 868.2875 - Differential pressure transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Differential pressure transducer. 868.2875 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2875 Differential pressure transducer. (a) Identification. A differential pressure transducer is a two-chambered device intended...

  8. 21 CFR 890.1615 - Miniature pressure transducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Miniature pressure transducer. 890.1615 Section... Miniature pressure transducer. (a) Identification. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical...

  9. 21 CFR 886.4610 - Ocular pressure applicator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ocular pressure applicator. 886.4610 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4610 Ocular pressure applicator. (a) Identification. An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type...

  10. 21 CFR 868.2600 - Airway pressure monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Airway pressure monitor. 868.2600 Section 868.2600...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2600 Airway pressure monitor. (a) Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper...

  11. 21 CFR 868.5935 - External negative pressure ventilator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External negative pressure ventilator. 868.5935... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5935 External negative pressure ventilator. (a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is...

  12. 21 CFR 886.4280 - Intraocular pressure measuring device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraocular pressure measuring device. 886.4280... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4280 Intraocular pressure measuring device. (a) Identification. An intraocular pressure measuring device is a manual or AC-powered...

  13. 21 CFR 868.1750 - Pressure plethysmograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pressure plethysmograph. 868.1750 Section 868.1750...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1750 Pressure plethysmograph. (a) Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and...

  14. 21 CFR 880.6450 - Skin pressure protectors.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skin pressure protectors. 880.6450 Section 880... Devices § 880.6450 Skin pressure protectors. (a) Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to...

  15. 21 CFR 868.1780 - Inspiratory airway pressure meter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Inspiratory airway pressure meter. 868.1780... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1780 Inspiratory airway pressure meter. (a) Identification. An inspiratory airway pressure meter is a device used to measure the...

  16. 21 CFR 868.2610 - Gas pressure gauge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas pressure gauge. 868.2610 Section 868.2610 Food... DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2610 Gas pressure gauge. (a) Identification. A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is...

  17. 21 CFR 870.1100 - Blood pressure alarm.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure alarm. 870.1100 Section 870.1100...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1100 Blood pressure alarm. (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood...

  18. 21 CFR 870.1110 - Blood pressure computer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure computer. 870.1110 Section 870.1110...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1110 Blood pressure computer. (a) Identification. A blood pressure computer is a device that accepts the electrical signal...

  19. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  20. 21 CFR 872.1820 - Dental x-ray exposure alignment device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position...

  1. 21 CFR 872.1810 - Intraoral source x-ray system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intraoral source x-ray system. 872.1810 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1810 Intraoral source x-ray system. (a) Identification. An intraoral source x-ray system is an electrically powered device that produces x-rays and...

  2. 21 CFR 872.1800 - Extraoral source x-ray system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Extraoral source x-ray system. 872.1800 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1800 Extraoral source x-ray system. (a) Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended...

  3. 21 CFR 872.1840 - Dental x-ray position indicating device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a...

  4. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Jet lavage. 880.5475 Section 880.5475 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... Jet lavage. (a) Identification. A jet lavage is a device used to clean a wound by a pulsatile jet...

  5. 21 CFR 872.4465 - Gas-powered jet injector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas-powered jet injector. 872.4465 Section 872...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4465 Gas-powered jet injector. (a) Identification. A gas-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe...

  6. 21 CFR 801.417 - Chlorofluorocarbon propellants.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chlorofluorocarbon propellants. 801.417 Section... (CONTINUED) MEDICAL DEVICES LABELING Special Requirements for Specific Devices § 801.417 Chlorofluorocarbon propellants. The use of chlorofluorocarbon in devices as propellants in self-pressurized containers...

  7. 21 CFR 808.89 - Rhode Island.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rhode Island. 808.89 Section 808.89 Food and Drugs... and Local Exemptions § 808.89 Rhode Island. The following Rhode Island medical device requirements are... from preemption under section 521(b) of the act: Rhode Island General Laws, Section 5-49-2.1,...

  8. 21 CFR 864.8500 - Lymphocyte separation medium.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lymphocyte separation medium. 864.8500 Section 864...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Hematology Reagents § 864.8500 Lymphocyte separation medium. (a) Identification. A lymphocyte separation medium is a device used to isolate lymphocytes...

  9. 21 CFR 872.3080 - Mercury and alloy dispenser.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mercury and alloy dispenser. 872.3080 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3080 Mercury and alloy dispenser. (a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure...

  10. 21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental amalgam, mercury, and amalgam alloy. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3070 Dental amalgam, mercury... elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam...

  11. 20 CFR 10.322 - Who pays for second opinion and referee examinations?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Who pays for second opinion and referee examinations? 10.322 Section 10.322 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF... second opinion and referee examinations? OWCP will pay second opinion and referee medical...

  12. 20 CFR 638.510 - Health care and services.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Health care and services. 638.510 Section 638... UNDER TITLE IV-B OF THE JOB TRAINING PARTNERSHIP ACT Center Operations § 638.510 Health care and services. The center operator shall provide a health program, including basic medical, dental, and...

  13. 21 CFR 862.3880 - Theophylline test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Theophylline test system. 862.3880 Section 862...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3880 Theophylline test system. (a) Identification. A theophylline test system is a device intended...

  14. 21 CFR 872.4535 - Dental diamond instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental diamond instrument. 872.4535 Section 872...) MEDICAL DEVICES DENTAL DEVICES Surgical Devices § 872.4535 Dental diamond instrument. (a) Identification. A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during...

  15. 21 CFR 862.1775 - Uric acid test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Uric acid test system. 862.1775 Section 862.1775...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.1775 Uric acid test system. (a) Identification. A uric acid test system is a device intended to...

  16. 21 CFR 872.6300 - Rubber dam and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Rubber dam and accessories. 872.6300 Section 872...) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6300 Rubber dam and accessories. (a) Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in...

  17. 21 CFR 888.3050 - Spinal interlaminal fixation orthosis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (a dislocation of the spinal column), and lower back syndrome. (b) Classification. Class II. ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Spinal interlaminal fixation orthosis. 888.3050... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3050 Spinal interlaminal...

  18. 21 CFR 870.3690 - Pacemaker test magnet.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered...

  19. 21 CFR 870.3620 - Pacemaker lead adaptor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that...

  20. 21 CFR 872.1850 - Lead-lined position indicator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Lead-lined position indicator. 872.1850 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1850 Lead-lined position indicator. (a) Identification. A lead-lined position indicator is a cone-shaped device lined with lead that is attached to...

  1. 20 CFR 220.114 - Evaluation of symptoms, including pain.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Evaluation of symptoms, including pain. 220... RETIREMENT ACT DETERMINING DISABILITY Medical Considerations § 220.114 Evaluation of symptoms, including pain...'s symptoms, including pain, and the extent to which the claimant's symptoms can reasonably...

  2. 21 CFR 886.1510 - Eye movement monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Eye movement monitor. 886.1510 Section 886.1510...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1510 Eye movement monitor. (a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and...

  3. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Eye sphere implant. 886.3320 Section 886.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3320 Eye sphere implant. (a) Identification. An...

  4. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended...

  5. 21 CFR 878.4410 - Low energy ultrasound wound cleaner.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Low energy ultrasound wound cleaner. 878.4410... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4410 Low energy ultrasound wound cleaner. (a) Identification. A low energy ultrasound wound cleaner is a device that...

  6. 21 CFR 878.3925 - Plastic surgery kit and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended...

  7. 21 CFR 872.3590 - Preformed plastic denture tooth.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Preformed plastic denture tooth. 872.3590 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3590 Preformed plastic denture tooth. (a) Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as...

  8. 21 CFR 872.5470 - Orthodontic plastic bracket.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Orthodontic plastic bracket. 872.5470 Section 872...) MEDICAL DEVICES DENTAL DEVICES Therapeutic Devices § 872.5470 Orthodontic plastic bracket. (a) Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to...

  9. 21 CFR 892.1990 - Transilluminator for breast evaluation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Transilluminator for breast evaluation. 892.1990... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1990 Transilluminator for breast... (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for...

  10. 21 CFR 878.4495 - Stainless steel suture.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Stainless steel suture. 878.4495 Section 878.4495...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4495 Stainless steel suture. (a) Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of...

  11. 21 CFR 872.3350 - Gold or stainless steel cusp.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gold or stainless steel cusp. 872.3350 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3350 Gold or stainless steel cusp. (a) Identification. A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or...

  12. 21 CFR 801.415 - Maximum acceptable level of ozone.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Maximum acceptable level of ozone. 801.415 Section... level of ozone. (a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in...

  13. 20 CFR 220.175 - Responsibility to notify the Board of events which affect disability.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Responsibility to notify the Board of events which affect disability. 220.175 Section 220.175 Employees' Benefits RAILROAD RETIREMENT BOARD... Substantial Gainful Activity or Medical Improvement § 220.175 Responsibility to notify the Board of...

  14. 21 CFR 882.5960 - Skull tongs for traction.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skull tongs for traction. 882.5960 Section 882...) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5960 Skull tongs for traction. (a) Identification. Skull tongs for traction is an instrument used to immobilize a patient with...

  15. 21 CFR 892.1600 - Angiographic x-ray system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Angiographic x-ray system. 892.1600 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1600 Angiographic x-ray system....

  16. 21 CFR 882.5975 - Human dura mater.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Human dura mater. 882.5975 Section 882.5975 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5975 Human dura mater....

  17. 21 CFR 808.61 - Hawaii.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hawaii. 808.61 Section 808.61 Food and Drugs FOOD... and Local Exemptions § 808.61 Hawaii. (a) The following Hawaii medical device requirements are... from preemption under section 521(b) of the act: Hawaii Revised Statutes, chapter 451A, §...

  18. 21 CFR 882.4535 - Nonpowered neurosurgical instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonpowered neurosurgical instrument. 882.4535 Section 882.4535 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4535...

  19. 21 CFR 882.4845 - Powered rongeur.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered rongeur. 882.4845 Section 882.4845 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4845 Powered rongeur. (a)...

  20. 21 CFR 882.4800 - Self-retaining retractor for neurosurgery.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Self-retaining retractor for neurosurgery. 882.4800 Section 882.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4800...