BEUDAMED
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    ULTRAPROX, INTERPROXIMAL TOOTHBRUSH

    FDA 510(k)
    FDA Class 1 ·Dental

    ADVANCE VESSEL ANALYSIS II

    FDA 510(k)
    FDA Class 2 ·Radiology

    BARNER SHOE COVERS & COVERBOOTS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GEMSTR 7 THPY ALT ST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2014

    MBT CEM KEEL TIB TRAY SZ2.5

    FDA Adverse Event
    Injury ·DEPUY IRELAND ? REG. # 9616671·Product code NJL·December 6, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 22, 2015

    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