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

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    THE PEAK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110980·STERILIZING CASE PLASTIC LARGE

    SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO FETAL ASSIST

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·January 17, 2013

    6461500 INFUSOR PUMP (1 LABEL)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 10, 2010

    IDENTITY XL DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017