BEUDAMED
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    ARGYLE MEDIASTINAL DRAIN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707034245·.018 Upper Stainless Steel Golden Natural Broad...

    STRADIS HEALTHCARE

    FDA UDI
    STRADIS MEDICAL, LLC·M75268223180·

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113614·PS-C Insert, Size 3 x 18mm

    Fresenius Liberty Select Cycler

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 7, 2012

    LUTHER L-CATH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC·Product code LJS·August 9, 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