BEUDAMED
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    DISPOSABLE RESCUE BREATHING DEVICE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    THROMBO-TEST (X)

    FDA 510(k)
    FDA Class 2 ·Hematology

    AXIOM ARISTOS FX PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLUM A + DRIVER NEW

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

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 3, 2012

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 7, 2010

    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