BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SURGICAL LIGHT

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

    LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    LEFORTE SYSTEM BONE PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·July 28, 2020

    SYMBIQ SCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 20, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 8, 2015

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·August 30, 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