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

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...

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

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

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

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...

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

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...

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...

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

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

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,...

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...