BEUDAMED
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    SP4044 & SP4055 LUX MODULES

    FDA 510(k)
    FDA Class 2 ·Dental

    artegral

    FDA UDI
    Merz Dental GmbH·D7091972026·posteriors; shade A3; size S; upper jaw

    RNK ELECTRONIC STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIAC PULSE GENERATOR, MODEL 150L

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FNL·January 22, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 27, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 31, 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