BEUDAMED
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    3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAMBRIDGE PC/GXT STRESS TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RIGHT ATRIAL CATHETER KITS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LAMITRODE S8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 17, 2014

    APOGEE SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·January 16, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 14, 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