BEUDAMED
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    CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HY-TEC TOTAL IGE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUATTRODE LEAD WIDE SPACED, 90 CM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·November 15, 2023

    JP 3-SPRING RES W/10FR PVC DRAIN/TRO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code GCY·February 6, 2013

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 21, 2014

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 4, 2011

    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