BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60

    FDA 510(k)
    FDA Class 2 ·Dental

    Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURFLO INJECTION PLUG

    FDA 510(k)
    FDA Class 2 ·General Hospital

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    ECHELON 60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 4, 2010

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 21, 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