BEUDAMED
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    DONALDSON NATURAL EYEPATCH

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

    XIA TITANIUM AND 4.5 SPINAL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Inclusive Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    PLUM XLM W/MODIFD B

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 14, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 7, 2010

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·December 6, 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