BEUDAMED
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    Kinos Total Ankle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 7, 2020

    HemiCAP MTP Resurfacing Hemi-Arthroplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·November 14, 2014

    DOUBLEPLAY LARGE BORE HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS INC·Product code DTL·July 24, 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