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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: …

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. ... Classify a Medical Device. Register and List a Device.

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, …

Are There "FDA Registered" or "FDA Certified" Medical …

    https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved
    The FDA provides several ways for you to check if the FDA approved or cleared a medical device or, as described below, if the FDA authorized the device to be …

Register a New Medical Device Facility: …

    https://www.access.fda.gov/drlm/help/RegisterANewMedicalDeviceFacility.html
    The extension to be dialed (if any) is optional, but recommended. Foreign addresses: the country code, the three-digit city code, and the phone number are …



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