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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
    When a business involved in the production and distribution of medical devices intended for use in the United States registers with the FDA, they do not receive a certificate from the FDA. It's important to understand: In addition, the FDA does not "certify" registration information for businesses that have … See more

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

    https://www.fda.gov/Medical-Devices
    Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

Recently-Approved Devices | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/recently-approved-devices
    Humanitarian Device Exemptions (HDE): Listing of devices that have been approved to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United …

How to Determine if Your Product is a Medical Device | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
    Step 1: Determine if your product meets the definition of a medical device per Section 201 (h) of the Food, Drug & Cosmetic Act. Step 2: Determine if an …



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