BEUDAMED
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    SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)

    FDA 510(k)
    FDA Class 2 ·Hematology

    DENTAL MATRIX BAND

    FDA 510(k)
    FDA Class 1 ·Dental

    Sidus Stem-Free Shoulder

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDO·April 21, 1997

    ST360 POLYAXIAL SCREW 5.5X30MM

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code KWQ·February 19, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 27, 2011

    PULSE GEN MODEL 104

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·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