BEUDAMED
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    GENERAL ELECTRIC AMX 110

    FDA 510(k)
    FDA Class 2 ·Radiology

    PowerFlow Implantable Apheresis IV Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SICKLE-CELL F TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    RESPIRONICS V-60 VENTILATOR

    FDA Adverse Event
    Injury ·Product code MNS·October 29, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·XOMED MFG JACKSONVILLE·Product code GWF·December 20, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014

    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