BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AUSTIN MODIFIED TOTAL OSSICULAR REPLACE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ARTHREX TIBIAL GRAFTBOLT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·December 22, 2009

    DAILIES TOTAL 1

    FDA Adverse Event
    Injury ·CIBA VISION GMBH·Product code MVN·June 12, 2014

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·January 2, 2013

    SI BRITE TIP

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DYB·November 9, 2010

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 16, 2018

    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