BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    EndoWrist Stapler 45 System and Stapler 45 Reloads

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

    FASTPACK TESTO IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GENTIAN CYSTATIN C IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2013

    FRAXEL SR 1500 LASER SYSTEM

    FDA Adverse Event
    Injury ·RELIANT TECHNOLOGIES·Product code GEX·February 22, 2007

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 17, 2008

    PERFORMER MULLINS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 20, 2023

    PERFORMER MULLINS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 24, 2024

    PERFORMER INTRODUCER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 4, 2022

    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