BEUDAMED
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    ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY

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

    P.F.C.

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295216216·P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 1.5 20 DEG

    The Red Head Collection Device, The Jordy Connection System

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

    CENTRICITY AW SUITE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 7, 2012

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·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