BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    AMERLEX LH RIA KIT (CODE IM2081)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEROYAL SURGICAL, UMBILICUP

    FDA 510(k)
    FDA Class 2 ·Hematology

    CLARISCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 7, 2014

    TI SPIRAL BLADE 100MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·November 6, 2012

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LGD·August 27, 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