Medical Device Recalls: Examination of Selected Cases : Report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives
The Office, 1989 - Medical instruments and apparatus - 66 pages
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adverse health consequences Analysis of Medical Appendix Approved Devices Recalled Brand Cardiac Pacemakers cdrh Class I Medical class I recalls component deaths or injuries defibrillators Description Recall date Descriptive Analysis Design Problem Device class device problem Device Recalls Involving FDA control number FDA learned FDA of recall FDA recall data Gastroenterology inspection Before recall Involving Premarket Approved learned of recall MDR report Medical Device Recalls Medical specialty natural or prosthetic notified FDA Ophthalmology Overview and Analysis pacemaker 3 Cardiovascular Patient death Patient injury percentages are based PMA-design recalls Premarket Approved Devices Problem Description Product Identification Description Profiles of Class Profiles of Medical prosthetic heart valve Quantity recalled units rate and rhythm Recall class recall data tape Recall Description Date Recall Description Recall recall Yes Recalls Involving Premarket recalls Percent Regulates cardiac rate Replacement heart valve Replaces natural rm Before recall rm During recall U.S. General Accounting urology valve 3 Cardiovascular vaporizer