BEUDAMED
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    ANGIOMED VAC-U-CUT BIOPSY NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Akros Fibulink Syndesmosis Repair Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO ENDO-EASE

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

    LIBERTY CYCLER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 28, 2014

    NONE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DRB·October 9, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·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