BEUDAMED
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    WECK INSTRUMENT CLEANER, CAT. NO. 850-103

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Vscan Extend

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    SIGMA 100 VVI

    FDA Adverse Event
    Injury ·MEDTRONIC OF CANADA LTD.·Product code DXY·October 8, 2010

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 28, 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