BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Morph DNA Steerable Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

    CAPSURE EPI

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·November 13, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    3.5MM CORTEX SCREW SELF-TAPPING 55MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 23, 2013

    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