BEUDAMED
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    PHASED ARRAY BREAST COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARTIMES BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·January 12, 2024

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 4, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 22, 2010

    HFD100 SKULL CLAMP ASSEMBLY

    FDA Adverse Event
    Injury ·IMRIS, INC.·Product code HBL·June 19, 2014

    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