BEUDAMED
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    AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SORIN AF 620 W/LOOP 10

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWE·June 25, 2010

    ULTRASOUND SCANNER TYPE 2102

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHREX OPES ELECTRODES AND ACCESSORIES

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

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·May 18, 2011

    14/16 LG TAPER M HEAD 36MM+5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 6, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012