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

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    ENTERA-FLO SPIKE SET

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

    6893209

    FDA Adverse Event
    Malfunction ·September 26, 2017

    Wego-Stainless Steel

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·November 27, 2017

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 25, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 2, 2013

    45 CM 5 FR. D/L GROSHONG NXT UPFT WITH MI AND TLS

    FDA Adverse Event
    Injury ·C. R. BARD INC., (BASD)·Product code LJS·October 29, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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