BEUDAMED
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    SERA FOR ANTINUCLEAR ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR28209451·Betaflex wires Titanium Straight-Arch-F. mand. ...

    AXSYM INTACT PTH, MODEL 2G06

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQY·April 15, 2014

    TI COLLAR WITH GROOVES

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MNH·November 6, 2012

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·August 31, 2010

    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