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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 Software as a...

AccessGUDID - Identify Your Medical Device

    https://accessgudid.nlm.nih.gov/
    The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have …

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

    Medical Device Tracking | FDA

      https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
      The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial …

    Importing Medical Devices | FDA

      https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
      Currently medical devices fall into one of three medical device classifications: Class I, Class II, and Class III. Class I includes devices with the lowest risk and Class III includes...

    Search Registration and Listing | FDA

      https://www.fda.gov/medical-devices/device-registration-and-listing/search-registration-and-listing
      Search the Registration & Listing database Establishment Registration and Medical Device Listing Files for Download Releasable establishment registration and listing information …

    Classify Your Medical Device | FDA

      https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
      Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. …

    Search the Releasable 510(k) Database | FDA

      https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database
      You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following …

    Find medical device and equipment sales …

      https://www.rephunter.net/find-medical-sales-reps.php
      Target the right medical device reps with our optimized search. Get your product into stores ASAP! Opt in and out of our service as your needs change—your unused contacts roll over to your next subscription period. …



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