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Try the next-generation Data Catalog at catalog-beta.data.gov and help shape it with your feedback.

665 datasets found
  • 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

    Orange Book

    U.S. Department of Health & Human Services —

    The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act...
  • Federal

    CLIA Currently Waived Analytes

    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

    Current and Resolved Drug Shortages and Discontinuations Reported to FDA

    U.S. Department of Health & Human Services —

    Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products.
  • Federal

    Enforcement Reports

    U.S. Department of Health & Human Services —

    Whereas not all recalls are announced in the media or on our Recalls press release page, all recalls montiored by FDA are included in FDA's weekly Enforcement Report...
  • Federal

    Total Product Life Cycle (TPLC)

    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

    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...
  • Federal

    FDA Recognized Consensus Standards

    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

    Premarket Approvals (PMA)

    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

    Approved Animal Drug Products (Green Book)

    U.S. Department of Health & Human Services —

    On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions, the...
  • Federal

    NHRIC (National Health Related Items Code)

    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

    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

    Recalls of Food and Dietary Supplements

    U.S. Department of Health & Human Services —

    Food producers recall their products from the marketplace when the products are mislabeled or when the food may present a health hazard to consumers because the food...
  • Federal

    Dorzolamide hydrochloride and timolol maleate preservative free

    U.S. Department of Health & Human Services —

    Dorzolamide Hydrochloride and Timolol Maleate is a preservative-free ophthalmic solution (eye drops) used to lower intraocular pressure in patients with glaucoma or...
  • Federal

    Dissolution Methods Database

    U.S. Department of Health & Human Services —

    For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on...
  • Federal

    Metronidazole oral

    U.S. Department of Health & Human Services —

    LIKMEZ is a prescription oral suspension containing metronidazole, an antibiotic that treats infections caused by certain bacteria and parasites. Each 5 mL provides...
  • Federal

    Dexmethylphenidate hydrochloride

    U.S. Department of Health & Human Services —

    Dexmethylphenidate Hydrochloride Extended-Release is a prescription stimulant medication used to treat attention deficit hyperactivity disorder (ADHD). It comes as...
  • Federal

    Bempedoic acid and ezetimibe

    U.S. Department of Health & Human Services —

    Nexlizet is a prescription tablet combining bempedoic acid (180 mg) and ezetimibe (10 mg) to help lower cholesterol levels. It works by reducing cholesterol...
  • Federal

    Liothyronine sodium

    U.S. Department of Health & Human Services —

    Liothyronine Sodium is a generic prescription medication used to treat thyroid hormone deficiency (hypothyroidism). It comes as oral tablets in strengths of 0.005 mg,...
  • 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...
665 datasets found

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