BEUDAMED
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    INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120

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

    INTRACEPT Intraosseous Nerve Ablation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    PERCUTANEOUS TRIAL LEAD

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 6, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 12, 2012

    STELLARIS 25GA POSTERIOR PACK W AFI&FT 6BX

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·June 24, 2015

    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