BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    M-BRACE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM

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

    AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESOLUTION CLIP CLIPPING DEVICE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·May 21, 2014

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·November 30, 2007

    TRIDENT 10 INSERT TRIAL 36MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·October 10, 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