BEUDAMED
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    AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELECTRO-CAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    URETEX SUP URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 26, 2013

    5.5MM SHORT SECONDARY PORT

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GDW·May 9, 2011

    COBAS 6000 CORE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 19, 2008

    AUTOMATED IMPELLA CONTROLLER

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·October 18, 2025

    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