BEUDAMED
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    CARDIOBEEPER IV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 4, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 30, 2012

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV·Product code FNL·October 27, 2010

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 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