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

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    Triathlon® Hinge Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARKEO, Wedge Fixation System

    FDA UDI
    Auxano Medical LLC·00810199190006·ARKEO Cotton Wedge Trial, 16x11x6.5

    Endo-Model Modular Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575302642·Proximal Tibial Spacer,Size x-small

    SYNTHES VECTRA-T SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUSTAIN Additional Implants

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Death ·EDWARDS LIFESCINECES·Product code KRH·December 1, 2008

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·August 30, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

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