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

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    WRIST ACTIGRAPH

    FDA 510(k)
    FDA Class 2 ·Neurology

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517380418·ARM15T Screw, 4x30mm Fixed

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111795·Modular Tibia Augment Size 3 x 4mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690131069·High Performance Revision Tibia Augment, Size 3...

    ACCUMETER ELECTRONIC URINEMETER SYSTEM

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

    CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS

    FDA 510(k)
    FDA Class 1 ·Radiology

    ALTRX +4 10D 36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 6, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 31, 2012

    HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·September 2, 2010

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Recall
    Terminated ·Omni Life Science·Product code JWH·August 9, 2012