BEUDAMED
    9 results · 19ms · 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.

    SV70 Ventilator (SV70)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283815·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197176194·Antrum Curette oval small 2mm, 2...

    Fuse Gastroscopy System

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

    SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014

    SYNCHRON LX20 PRO CLINICAL CHEMISTRY SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 16, 2011

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 29, 2013

    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