BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    ENDOTRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214561·CUSTOM SURGICAL KIT VARICOSITY BASIC PACK

    ER150/M2

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

    AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RECLAIM DIST REAMER EXTENSION

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·May 20, 2014

    UNKNOWN REJUVENATE HIP DEVICE

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 23, 2012

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·August 31, 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