BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    DISPOSABLE IRRIGA/ASPIR. SYSTEM

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

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214961·CUSTOM SURGICAL KIT VEIN PACK

    STRADIS HEALTHCARE

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214960·CUSTOM SURGICAL KIT VEIN PACK

    HMS-DHR-3 NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    LTC MED SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·November 6, 2012

    NATURAL KNEE II CONGRUENT TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER INC.·Product code JWH·August 25, 2010

    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