BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PARTIAL OSSICULAR REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DECLIPSESPECT VIEWER

    FDA 510(k)
    FDA Class 1 ·Radiology

    PINNACLE MTL INS NEUT40IDX58OD

    FDA Adverse Event
    Death ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 21, 2014

    IMPLANT PDS3000 6PK PILLAR PALATAL EN

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code LRK·October 29, 2012

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR - GRIP HANDLE - 23 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GEI·January 16, 2008

    ABBVIE J

    FDA Adverse Event
    Injury ·ABBVIE - MEDICAL DEVICE CENTER·Product code KNT·April 27, 2016

    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

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021