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

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    NORTON FLOW DIRECTED THERMODILUTION CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    R & D BODY FLUID CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENVOY DISTAL ACCESS GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·May 20, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 31, 2012

    16FR EDWARDS EXPANDABLE SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 4, 2015

    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