BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    SANDHILL DMS

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

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268215881·CUSTOM SURGICAL KIT VEIN PACK

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M7526821588R11·CUSTOM SURGICAL KIT VEIN PACK

    RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POWERLINK SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·May 20, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 6, 2012

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 27, 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