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

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    MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRASAFE PLUS PASSIVE NEEDLE GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WECK AUTO ENDO5 ML APPLIER

    FDA Adverse Event
    Malfunction ·Product code GDO·February 20, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 10, 2012

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC·Product code NDN·August 26, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    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