BEUDAMED
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    MODUFLEX NEONATAL VENTILATOR SET

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PROGRIP LAPAROSCOPIC SELF-FIXATING MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES

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

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 1, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 9, 2012

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·July 30, 2007

    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