BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Sutter RaVoR Bipolar Electrodes

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VRLXP, MODEL XP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASTRA TECH IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 14, 2015

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 4, 2011

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 30, 2015

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

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