BEUDAMED
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    ELECTROENCEPHALOGRAPH ECG-6151

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209128556·

    GYRUS ENT SOMNOPLASTY GENERATOR

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

    MOSAIQ ONCOLOGY INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    FACET WEDGE MED TAN GREEN

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code KWP·May 20, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 5, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 23, 2010

    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.

    FDA Enforcement
    Class I ·Terminated·BERLIN HEART GMBH·May 31, 2023

    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