BEUDAMED
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    JEJENOSTOMY FEEDING TUBE

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

    PHOSPHATE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 18, 2013

    STARBURST XLIE WITH ATTACHED TUBING 12CM

    FDA Adverse Event
    Other ·ANGIODYNAMICS·Product code GEI·January 20, 2011

    PENUMBRA SYSTEM SEPARATOR 041

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·July 31, 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