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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
    Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution of medical devices...

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
    To search for FDA-approved or FDA-cleared products by device name or company name: Go to the Devices@FDA Database. In the Enter a search term in the …

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

    https://www.fda.gov/Medical-Devices
    Public Health Emergency Updates. Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation. "Our center …

Register a New Medical Device Facility: Step-by-Step …

    https://www.access.fda.gov/drlm/help/RegisterANewMedicalDeviceFacility.html
    Humanitarian Device Exemption (HDE) number Investigational New Drug (IND) number New Drug Application (NDA) number If you believe your device is exempt from FDA premarket notification...

Establishment Registration & Device Listing - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm
    medical device manufacturers registered with FDA and medical devices listed with FDA Note: Registration of a device establishment, assignment of a registration number, or...



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