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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...
Search relevance: 1.00 | Views last month: 101 | Catalog Last Checked: July 31, 2026 at 09:54 PM -
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, distributor reports since...
Search relevance: 1.00 | Views last month: 93 | Catalog Last Checked: July 31, 2026 at 09:55 PM -
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)...
Search relevance: 1.00 | Views last month: 72 | Catalog Last Checked: July 31, 2026 at 09:45 PM -
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and...
Search relevance: 1.00 | Views last month: 61 | Catalog Last Checked: July 31, 2026 at 09:28 PM -
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...
Search relevance: 1.00 | Views last month: 51 | Catalog Last Checked: July 31, 2026 at 10:01 PM -
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),...
Search relevance: 1.00 | Views last month: 33 | Catalog Last Checked: July 31, 2026 at 09:11 PM -
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...
Search relevance: 1.00 | Views last month: 26 | Catalog Last Checked: July 31, 2026 at 09:05 PM -
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...
Search relevance: 1.00 | Views last month: 15 | Catalog Last Checked: July 31, 2026 at 09:10 PM -
The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.
Search relevance: 1.00 | Views last month: 10 | Catalog Last Checked: July 31, 2026 at 09:03 PM -
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 years 1992 through 1996.
Search relevance: 1.00 | Views last month: 8 | Catalog Last Checked: July 31, 2026 at 09:52 PM -
This database contains a list of classified medical device recalls since November 1, 2002
Search relevance: 1.00 | Views last month: 7 | Catalog Last Checked: July 31, 2026 at 09:29 PM -
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...
Search relevance: 1.00 | Views last month: 7 | Catalog Last Checked: July 31, 2026 at 09:01 PM -
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 National Drug...
Search relevance: 1.00 | Views last month: 5 | Catalog Last Checked: July 31, 2026 at 09:18 PM -
Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA
Search relevance: 1.00 | Views last month: 5 | Catalog Last Checked: July 31, 2026 at 09:17 PM -
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...
Search relevance: 1.00 | Views last month: 5 | Catalog Last Checked: July 31, 2026 at 09:35 PM -
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...
Search relevance: 1.00 | Views last month: 4 | Catalog Last Checked: July 31, 2026 at 10:02 PM -
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.
Search relevance: 1.00 | Views last month: 3 | Catalog Last Checked: July 31, 2026 at 10:02 PM -
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...
Search relevance: 1.00 | Views last month: 3 | Catalog Last Checked: July 31, 2026 at 09:58 PM -
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...
Search relevance: 1.00 | Views last month: 2 | Catalog Last Checked: July 31, 2026 at 09:40 PM -
This database contains a list of classified medical device recalls since November 1, 2002
Search relevance: 1.00 | Views last month: 2 | Catalog Last Checked: July 31, 2026 at 09:05 PM
