BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG

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

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189640·AK3 PS Instruments Left/Right Pan

    OPTICS ONE

    FDA UDI
    MEDICAL TECHNIQUE, INC.·00815384021981·Laser/Video Camera Drape 6 x 96 Snap-off End

    Medline-Microtek

    FDA UDI
    Microtek Medical LLC·00748426141531·Arthroscopy Video Camera Drape with Adhesive St...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189633·APEX Knee System PS Instruments- Left/Right Pan...

    ALL-IN-ONE CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    R2GATE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRA THERAPEUTIC PLASMA EXCHANGE SET

    FDA Adverse Event
    Injury ·CARIDIANBCT·Product code LKN·October 28, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012

    2.4MM TI VA-LCP 2-CLMN VLR DST-RAD PL 6H HD/2H SHAFT/RT-STER

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·October 9, 2015

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 9, 2015

    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 9, 2015

    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 9, 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