BEUDAMED
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    TEST SYSTEM, RIA CORTISOL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GBT Visigate

    FDA UDI
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT·07615208474176·GBT Visigate Starter Kit / 15/15

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Polux , Minerva and Atropos PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 19, 2014

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 26, 2012

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·July 16, 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