BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    FORTIFY Corpectomy Spacers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·October 15, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 17, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 24, 2011

    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