BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Simpliciti® Shoulder System

    FDA UDI
    TORNIER, INC.·00846832091706·

    Simpliciti™

    FDA UDI
    TORNIER, INC.·00846832061334·

    HRK-63 KNEE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 21, 2013

    PREFYX PPS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 14, 2011

    X-STOP IPD SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC.·Product code NQO·August 14, 2008

    GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 1 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 14, 2016

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024