Datasets

24 datasets

HealthData.Gov

CDRH Inspections Database

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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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

FDA Recognized Consensus Standards

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…

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Updated Oct 29, 2026

HealthData.Gov

Product Classification

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

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

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…

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Updated Oct 29, 2026

HealthData.Gov

Establishment Registration & Device Listing

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…

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Updated Oct 29, 2026

HealthData.Gov

GUDID Download

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…

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Updated Oct 29, 2026

HealthData.Gov

Medical and Radiation Emitting Device Recalls

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

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Updated Oct 29, 2026

HealthData.Gov

MedSun Reports

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…

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Updated Oct 29, 2026

HealthData.Gov

Mammography Facilities

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…

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Updated Oct 29, 2026

HealthData.Gov

Clinical Laboratory Improvement Amendments

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.

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Updated Oct 29, 2026

HealthData.Gov

CLIA Currently Waived Analytes

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…

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Updated Oct 29, 2026

HealthData.Gov

Recalls of Medical Devices

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

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Updated Oct 29, 2026

HealthData.Gov

Radiation Emitting Product Corrective Actions and Recalls

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…

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Updated Oct 29, 2026

HealthData.Gov

Premarket Approvals (PMA)

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…

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Updated Oct 29, 2026

HealthData.Gov

522 Postmarket Surveillance Studies

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

Premarket Notifications (510(k)s)

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

HealthData.Gov

Radiation-emitting Electronic Product Codes

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 code, a descriptor for…

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Updated Oct 29, 2026

HealthData.Gov

Post-Approval Studies

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

IVD Home Use Lab Tests (Over The Counter) Tests

Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA

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Updated Oct 29, 2026