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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: October 31, 2013

MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease Control and Prevention (CDC)...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: July 16, 2025

This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: July 16, 2025

This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA),...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: July 16, 2025

This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to the level of CDRH...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: July 16, 2025

The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

This database contains a list of classified medical device recalls since November 1, 2002

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: July 31, 1996

This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1992 through 1996.

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering systems such as the National Drug...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 13, 2013

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002. The primary goal for MedSun is to work collaboratively with the clinical community to identify,...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of Radiology (ACR), and the States of...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

The CDRH FOIA electronic reading room contains frequently requested information via the Freedom of Information Act from the Center for Devices and Radiological Health.

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: July 16, 2025

Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the releasable...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 01, 2013

This database contains product names and associated information developed by the Center for all products, both medical and non-medical, which emit radiation. It includes a three letter product...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: February 04, 2014

The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). Unique...

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• Organization: U.S. Department of Health & Human Services
• Dataset Last Updated: November 13, 2013

This database contains a list of classified medical device recalls since November 1, 2002

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