BEUDAMED
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    CRYO CHECK FACTOR IX DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    PEEK Corpectomy

    FDA UDI
    Nuvasive, Inc.·00887517623164·PEEK Corp Core, Ø12x26mm

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902974304·INSTRUMENT 6971226 IMP TRIAL 6X12MM

    TOKUYAMA UNIVERSAL BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·February 1, 2013

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 26, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·July 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