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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 regulation of a given…
Updated Oct 29, 2026
HealthData.Gov
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.
Updated Oct 29, 2026
HealthData.Gov
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 information submitted including…
Updated Oct 29, 2026
HealthData.Gov
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and…
Updated Oct 29, 2026
HealthData.Gov
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 appropriate decision…
Updated Oct 29, 2026
HealthData.Gov
A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. As a pilot…
Updated Oct 29, 2026
HealthData.Gov
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 device identification…
Updated Oct 29, 2026
HealthData.Gov
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, understand, and solve…
Updated Oct 29, 2026
HealthData.Gov
This database contains a list of classified medical device recalls since November 1, 2002
Updated Oct 29, 2026
HealthData.Gov
This database contains a list of classified medical device recalls since November 1, 2002
Updated Oct 29, 2026
HealthData.Gov
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) prior to that date. CLIA…
Updated Oct 29, 2026
HealthData.Gov
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 Arkansas, Iowa, and…
Updated Oct 29, 2026
HealthData.Gov
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 Act. The program helps…
Updated Oct 29, 2026
HealthData.Gov
This database provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and noncompliant products from the market. Searches may be done by…
Updated Oct 29, 2026
HealthData.Gov
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 Application (PMA) is, in…
Updated Oct 29, 2026
HealthData.Gov
This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.
Updated Oct 29, 2026
HealthData.Gov
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development…
Updated Oct 29, 2026
HealthData.Gov
Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA
Updated Oct 29, 2026
HealthData.Gov
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), Premarket…
Updated Oct 29, 2026
HealthData.Gov
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 that will be…
Updated Oct 29, 2026
