BEUDAMED
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    BETA THALQUIK COLUMN #5341

    FDA 510(k)
    FDA Class 2 ·Hematology

    1.5X7MM HT SD X-DR SCR 5-PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 4, 2021

    1.5X7MM HT SD X-DR SCR 5-PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 4, 2021

    XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXIMA BILIARY CATHETER

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

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 21, 2014

    TRIDENT CUP TIP

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·October 10, 2012

    WANDA PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·September 2, 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