BEUDAMED
    9 results · 34ms · Sources: EU EUDAMED, US FDA

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    ROSEN'S STAPES NEEDLE EXPLORER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OSTEOMED CRANIAL FLAP FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ECLIPSE

    FDA Adverse Event
    Other ·I-FLOW CORPORATION·Product code MEB·July 10, 2008

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·May 20, 2014

    MATOME STEREOTACTIC 11 G PROBE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·December 6, 2007

    LPS FEM TO SLEEVE ADAPTER +0

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JWH·November 7, 2012

    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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015