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    BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G5869916180·instrument id roll tape, withstands repeated st...

    320 P37,SY,2L,STKR

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828137812·320 P37,SY,2L,STKR

    VITOMATRIX

    FDA 510(k)
    FDA Class 2 ·Dental

    SleepTight Mouthpiece STZ

    FDA 510(k)
    FDA Class 2 ·Dental

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 6, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    ENTRUST

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 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