BEUDAMED
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    DSL 9100 IGF-II IRMA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799004420·

    Ambler Surgical

    FDA UDI
    AMBLER SURGICAL CORP.·10190660200128·Slit knife, 2.75mm wide, angled double-bevel sy...

    VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OWL URF-3AP

    FDA 510(k)
    FDA Class 2 ·Neurology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·January 11, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMELRY NELLCO·Product code CBK·June 23, 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