BEUDAMED
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    HAEM-C PLUS BLOOD REFERENCE CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    Stradis Healthcare

    FDA UDI
    STRADIS MEDICAL, LLC·M7526821956·Custom Surgical Kit

    MHS MED LIGHT 1000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TISSUE-TEK III TISSUE EMBEDDING CENTER

    FDA 510(k)

    M2A 38MMX50MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 28, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 1, 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