BEUDAMED
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    ACE UNILATERAL FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECIALIST

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295216117·SPECIALIST FIXATION PIN LNG

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916492181·Multi-Axial Cannulated Screw, Ø10.5 x 90mm, Ø6....

    XN CHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    BUN KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 10, 2014

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·December 6, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 22, 2015

    PFC TB TRY TRL FIX PIN LG (4EA

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LXH·October 28, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012