BEUDAMED
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    DYTRACT FLOW RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    Key Scientific Products Incorporated·00850041798028·PEP REAGENT

    N/A

    FDA UDI
    Key Scientific Products Incorporated·00850041798042·Pep ReagentT

    SYNCHRON CREATINE KINASE REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code CGS·June 17, 2011

    OARtrac System

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 28, 2013

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·January 14, 2011

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·August 6, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012