BEUDAMED
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    ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE OXYGEN GENERATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIPU1

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code LFL·April 1, 2014

    SYSTEM 98

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 29, 2012

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES, INC.·Product code LWR·September 30, 2010

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012