BEUDAMED
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    THERMOELASTOMER HOT/COLD COMPRESS-7187-

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101148·TOOKE CORNEAL KNIFE

    ARIX RAD ACQUISITION CONSOLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DENTSPLY PROFESSIONAL·Product code EKX·February 28, 2014

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·November 16, 2007

    RSP SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·October 25, 2012

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

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