BEUDAMED
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    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

    FDA 510(k)
    FDA Class 2 ·Radiology

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984563·anteriors; shade C4; mould Q 83

    OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNL·February 28, 2013

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·February 2, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 6, 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