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U.S. Department of Health and Human Services

About FDA

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Postmarket Performance and Safety

Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations to ensure safety and effectiveness once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, and reporting serious injuries.

The following databases include safety information for medical devices including reports from manufacturers and health care facilities and recall notifications.


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