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26 datasets found
  • Federal

    MDR (Medical Device Reporting)    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

    Establishment Registration & Device Listing    recent views

    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...
  • Federal

    Total Product Life Cycle (TPLC)    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

    FDA Recognized Consensus Standards    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

    CLIA Currently Waived Analytes    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

    Product Classification    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

    MAUDE (Manufacturer and User Facility Device Experience)    recent views

    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

    NHRIC (National Health Related Items Code)    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

    Premarket Notifications (510(k)s)    recent views

    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

    Premarket Approvals (PMA)    recent views

    U.S. Department of Health & Human Services —

    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...
  • Federal

    MedSun Reports    recent views

    U.S. Department of Health & Human Services —

    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...
  • Federal

    IVD Home Use Lab Tests (Over The Counter) Tests    recent views

    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

    Code of Federal Regulations Title 21    recent views

    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

    Mammography Facilities    recent views

    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

    Recalls of Medical Devices    recent views

    U.S. Department of Health & Human Services —

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

    Radiation-emitting Electronic Product Codes    recent views

    U.S. Department of Health & Human Services —

    This database contains product names and associated information developed by the Center for all products, both medical and non-medical, which emit radiation. It...
  • Federal

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

    U.S. Department of Health & Human Services —

    A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved...
  • Federal

    X-Ray Assembler Data    recent views

    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

    CDRH FOIA Electronic Reading Room    recent views

    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

    Medical and Radiation Emitting Device Recalls    recent views

    U.S. Department of Health & Human Services —

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

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