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Resources for You (Medical Devices)

Information of special interest to specific audiences and stakeholders.

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Recently-Approved Devices

Learn about the latest device approvals, including what medical uses the device is cleared or approved for, when it can be used, and when it should not be used.

510(k) Premarket Clearances

Find out which devices have been cleared recently through the 510(k) review process or search the 510(k) Premarket Notification database.

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Medical Device Safety

Safety Communications

The FDA posts Medical Device Safety Communications to describe FDA’s analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management.

Letters to Health Care Providers

The FDA posts the letters it sends to health care providers about safety concerns with medical devices used in health care facilities.

List of Device Recalls

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

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Contact Us

Contact Point
Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

(800) 638-2041
(301) 796-7100

Hours Available

Office of Communication, Information Disclosure, Training and Education

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Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.

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