Medical Device Establishment Registration


Book Description







Medical Devices


Book Description




Public Health Effectiveness of the FDA 510(k) Clearance Process


Book Description

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.




Medical Device Establishment Registration


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Medical Device Register


Book Description

Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.




Medical Device Listing


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Execution of Public Law 94-295


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