BEUDAMED
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    ADVANCED D-DIMER

    FDA 510(k)
    FDA Class 2 ·Hematology

    VivaChek Blood Glucose and B-Ketone Monitoring System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTOCAT 2 WAVE GERMAN

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DSP·March 1, 2013

    INSYNC MAXIMO

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·August 8, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 7, 2011

    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