BEUDAMED
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    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Azurion 5 M12; System Code: (1)722227, (2)722231;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021