BEUDAMED
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    YEAST IDENTIFICATION PANEL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916492150·Multi-Axial Cannulated Screw, Ø10.5 x 75mm, Ø6....

    ROCKER-SOLE CAST SANDAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CareSens Pen Needle, Softip Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·December 5, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 22, 2015

    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