BEUDAMED
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    MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Roosin Xeroform Petrolatum Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    GYNECARE TVT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 18, 2014

    ENDOPATH** XCEL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 25, 2010

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 20, 2012

    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