BEUDAMED
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    MODEL 16800 TREND RECORDER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    Legacy

    FDA UDI
    Gc Orthodontics America Inc.·E53582161200001·LEGACY 1. MOLAR UPR RGT SZ 12

    ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSTART MRX- EMS DEFIB

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 16, 2014

    ACTIVA

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code MHY·November 6, 2012

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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