Search results for cdrh
Filters
13 datasets for “cdrh”
- Data.gov Catalog
CDRH Inspections Database
U.S. Food and Drug AdministrationUpdated 16 Jul 2025
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 …
- HTML
- Data.gov Catalog
CDRH FOIA Electronic Reading Room
U.S. Food and Drug AdministrationUpdated 1 Nov 2013
The CDRH FOIA electronic reading room contains frequently requested information via the Freedom of Information Act from the …
- Data.gov Catalog
MDR (Medical Device Reporting)
U.S. Food and Drug AdministrationUpdated 31 Jul 1996
This database allows you to search the CDRH's database information on medical devices which may have malfunctioned …
- HTML
- Data.gov Catalog
Product Classification
U.S. Food and Drug AdministrationUpdated 16 Jul 2025
… product code and a Device Class that refers to the level of CDRH regulation of a given device.
- ZIP
- Data.gov Catalog
CLIA Currently Waived Analytes
U.S. Food and Drug AdministrationUpdated 1 Nov 2013
This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since …
- HTML
- Data.gov Catalog
Establishment Registration & Device Listing
U.S. Food and Drug AdministrationUpdated 16 Jul 2025
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices …
- HTML
- Data.gov Catalog
MAUDE (Manufacturer and User Facility Device Experience)
U.S. Food and Drug AdministrationUpdated 31 Oct 2013
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since …
- HTML
- Data.gov Catalog
Total Product Life Cycle (TPLC)
U.S. Food and Drug AdministrationUpdated 1 Nov 2013
… It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and …
- HTML
- Data.gov Catalog
Premarket Approvals (PMA)
U.S. Food and Drug AdministrationUpdated 1 Nov 2013
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of …
- HTML
- Data.gov Catalog
NHRIC (National Health Related Items Code)
U.S. Food and Drug AdministrationUpdated 1 Nov 2013
The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages …
- HTML
- Data.gov Catalog
FDA Recognized Consensus Standards
U.S. Food and Drug AdministrationUpdated 16 Jul 2025
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to …
- HTML
- Data.gov Catalog
Premarket Notifications (510(k)s)
U.S. Food and Drug AdministrationUpdated 1 Nov 2013
Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce …
- ZIP
- Data.gov Catalog
Mammography Facilities
U.S. Food and Drug AdministrationUpdated 1 Nov 2013
The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies …
- HTML