BEUDAMED
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    ASSERACHROM TOTAL PROTEIN S KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517391469·ARM15S Screw, 4x40mm Fixed

    APEX Revision Knee

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

    ZAVATION

    FDA UDI
    Zavation LLC·00842166117426·Polyaxial Screw 4.0mm x 40mm

    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

    I.V. DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 16, 2010

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CALI·Product code KDI·July 23, 2014

    PUMP MMT-515NAB PRDGM INS V2.1 BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·September 10, 2007

    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