BEUDAMED
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    CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GAMMA 3 LAG SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 17, 2013

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·October 26, 2010

    ALLURE QUADRA RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 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