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Establishment Registration & Device Listing - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm
    This database includes: medical device manufacturers registered with FDA and. medical devices listed with FDA. Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval …

Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. ... CDRH recently issued two warning letters to a leading …

Medical Device Databases | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
    Apr 6, 2022

Device Registration and Listing | FDA

    https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: …



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