BEUDAMED
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    PROVAC WOUND DRAINAGE & HEALING SYS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NUROS BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    GOODBABY·Product code IOR·May 30, 2014

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 20, 2012

    PUMP MMT-712RNAL PRDGM INS CL EN US RC

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LGZ·September 17, 2010

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018