BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    DURA II PENILE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540731845·HYBRID MMF MODULE WITH LID

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113270·PS Insert, Size 4 x 20mm

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776200763·JENSEN CAPSULE PISHER G LENGTH

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110942·STERILIZING CASE PLASTIC SMALL

    STERILE BLUNT FOR SINGLE USE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Saffron Fixation System

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

    IMUFLEX DISPOSBLES

    FDA Adverse Event
    TERUMO BCT·Product code LKN·January 17, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·December 10, 2010

    IDENTITY ADX XL DR

    FDA Adverse Event
    Malfunction ·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