BEUDAMED
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    CRITIKON #817 ESOPHAGEAL MULTI-PROBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    G-2 VERSION 3, MODEL 10049

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GENESYS PRESSFT SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUMMIT POR TAPER SZ5 STD OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 20, 2014

    OUTBACK RE-ENTRY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQY·November 7, 2012

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·June 5, 2015

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012