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.

Premarket Approvals (PMA) for Class III Devices

Find out which devices have been approved recently through the PMA review process or search the Premarket Approval (PMA) database.

Humanitarian Device Exception (HDE) Approvals

See which devices have been approved through the Humanitarian Device Exception (HDE) review process

510(k) Premarket Notification Database

Device Registration and Listing Database

Premarket Approvals (PMA) Database

All Medical Device Databases

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.