26 datasets found for "organization:((hhs-gov) OR (nlm-nih-gov) OR (cdc-hhs-gov) OR (acf-hhs-gov) OR (ahrq-hhs-gov) OR (cms-hhs-gov) OR (aoa-hhs-gov) OR (hrsa-gov) OR (samhsa-hhs-gov) OR (fda-hhs-gov) OR (ihs-hhs-gov) OR (nih-hhs-gov))"
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Federal
CLIA Currently Waived Analytes 20 recent views
U.S. Department of Health & Human Services —
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... -
Federal
FDA Recognized Consensus Standards 17 recent views
U.S. Department of Health & Human Services —
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information... -
Federal
Total Product Life Cycle (TPLC) 15 recent views
U.S. Department of Health & Human Services —
The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases... -
Federal
NHRIC (National Health Related Items Code) 13 recent views
U.S. Department of Health & Human Services —
The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering... -
Federal
Product Classification 11 recent views
U.S. Department of Health & Human Services —
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... -
Federal
MDR (Medical Device Reporting) 10 recent views
U.S. Department of Health & Human Services —
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... -
Federal
Premarket Notifications (510(k)s)
U.S. Department of Health & Human Services —
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... -
Federal
GUDID Download
U.S. Department of Health & Human Services —
The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique... -
Federal
CDRH FOIA Electronic Reading Room
U.S. Department of Health & Human Services —
The CDRH FOIA electronic reading room contains frequently requested information via the Freedom of Information Act from the Center for Devices and Radiological Health. -
Federal
Recalls of Medical Devices
U.S. Department of Health & Human Services —
This database contains a list of classified medical device recalls since November 1, 2002 -
Federal
Radiation Emitting Product Corrective Actions and Recalls
U.S. Department of Health & Human Services —
This database provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and... -
Federal
Code of Federal Regulations Title 21
U.S. Department of Health & Human Services —
This database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs. -
Federal
CDRH Inspections Database
U.S. Department of Health & Human Services —
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present. -
Federal
Mammography Facilities
U.S. Department of Health & Human Services —
The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of... -
Federal
MAUDE (Manufacturer and User Facility Device Experience)
U.S. Department of Health & Human Services —
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since... -
Federal
Clinical Laboratory Improvement Amendments
U.S. Department of Health & Human Services —
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... -
Federal
X-Ray Assembler Data
U.S. Department of Health & Human Services —
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... -
Federal
IVD Home Use Lab Tests (Over The Counter) Tests
U.S. Department of Health & Human Services —
Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA -
Federal
Medical and Radiation Emitting Device Recalls
U.S. Department of Health & Human Services —
This database contains a list of classified medical device recalls since November 1, 2002 -
Federal
Establishment Registration & Device Listing
U.S. Department of Health & Human Services —
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices...
26 datasets found for "organization:((hhs-gov) OR (nlm-nih-gov) OR (cdc-hhs-gov) OR (acf-hhs-gov) OR (ahrq-hhs-gov) OR (cms-hhs-gov) OR (aoa-hhs-gov) OR (hrsa-gov) OR (samhsa-hhs-gov) OR (fda-hhs-gov) OR (ihs-hhs-gov) OR (nih-hhs-gov))"