BEUDAMED
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    ENTERAL NUTRITION 1

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

    EEGER4 MODEL 4.3

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY

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

    NC TENKU DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·November 7, 2012

    PLUM A+ DRIVER EDITI

    FDA Adverse Event
    Malfunction ·NHOSPIRA COSTA RICA LTD.·Product code FRN·February 5, 2014

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·August 25, 2010

    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