BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    I.V. DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517380432·ARM15T Screw, 4x40mm Fixed

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111801·Modular Tibia Augment Size 4 x 4mm

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209125289·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690131083·High Performance Revision Tibia Augment, Size 4...

    LungFlow Basket Catheter

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MINATURE PRESSURE TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 6, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·October 5, 2010

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 31, 2012

    STEALTHSTATION® S7

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 17, 2020

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. 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 4 x 4mm Ref: KC-54040. 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