BEUDAMED
    8 results · 35ms · Sources: EU EUDAMED, US FDA

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    AM. PH. STERILE SINGLE-USE URETHRAL CATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DYNA LOCKING ANKLE NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    V SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code GZB·May 20, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 5, 2015

    THAL-QUICK CHEST TUBE SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GBX·January 2, 2020

    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