BEUDAMED
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    SABRE MULTI-USE TROCAR SYSTEM

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

    DG PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·May 20, 2014

    MEDTRONIC.SIGMA

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·February 9, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 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