BEUDAMED
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    PERITONE DISPOSAL SHEATH - RUBBER AND VINYL

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

    EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BC100 BODY COMPOSITION ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 7, 2010

    TRILOGY O2

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·December 5, 2012

    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