BEUDAMED
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    MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JOBST Maternity

    FDA UDI
    BSN MEDICAL, INC.·04042809643657·OPAQUE MATERNITY 20-30 MM HG WAIST HIGH ZIG ZAG...

    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    10NM TORQUE LIMITING HANDLE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code LXH·October 5, 2010

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 31, 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