BEUDAMED
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    ABCOM 1 CARDIAC OUTPUT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Portrait CSS01

    FDA UDI
    GE Medical Systems Information Technologies, Inc.·00195278341129·PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1...

    NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM

    FDA 510(k)
    FDA Class 2 ·Dental

    DIALYSIS MACHINE, CENTRY II

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

    ETS LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 12, 2014

    STRATA II SHUNT ASSEMBLY, SMALL, 90 CM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·October 7, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 12, 2012

    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