BEUDAMED
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    ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ONE-STEP PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG

    FDA 510(k)
    FDA Class 2 ·Hematology

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS, LLC/IKARIA·Product code MRN·November 10, 2010

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·January 28, 2013

    PINN SECTOR W/GRIPTION 58MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 14, 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