BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    SOFT GRIP UNI-HANDLE

    FDA 510(k)
    FDA Class 1 ·Dental

    Sphero Attachment

    FDA UDI
    Preat Corporation·00842092115541·Sphero Flex Abutment PrimaConnex 4.1mm x 3mm

    NEUROTECH BAXOLVE TYPE 294

    FDA 510(k)
    FDA Class 2 ·Neurology

    LATIS SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code CAW·May 21, 2014

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·October 29, 2012

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 2, 2010

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012