BEUDAMED
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    INTRODUCER FOR PTCA GUIDING CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZAVATION HEAD ADJUSTER

    FDA UDI
    Zavation LLC·00197157014575·TIGER 2 HEAD ADJUSTER

    Zavation

    FDA UDI
    Zavation LLC·00197157002169·Counter Torque Wrench

    PROTHROMBIN REFERENCE PLASMA (HUMAN)

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024140660·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024140677·

    SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·SIGMA INTL.·Product code FRN·January 31, 2014

    PRESESS

    FDA Adverse Event
    Malfunction ·INVIVO CORPORATION·Product code MHX·October 26, 2010

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·November 15, 2012

    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    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