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    Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376367118·IdentiTi ALIF SA, T40 Removal Driver, Straight

    Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ORTHOPACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    8010042-2008-00158

    FDA Adverse Event
    Malfunction ·Product code CBK·October 2, 2008

    SROM STM STD 36+12L 13X18

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LPH·September 4, 2011

    UNIVERSAL II

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 16, 2013

    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