BEUDAMED
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    STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CITADEL ANTERIOR LUMBAR PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUJIFILM Surgical System

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

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 23, 2014

    VIRTUOSO II DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·October 9, 2010

    DLT TS CER HD 12/14 36MM +5.0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·December 10, 2012

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020