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

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    MINI-H-FIXATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SpineWand

    FDA UDI
    MORGAN STEER ORTHOPAEDICS LIMITED·05060696460019·Perc DLG Convenience Pack inc 17 gauge 8” Crawf...

    Coblation

    FDA UDI
    Smith & Nephew, Inc.·00817470004489·PERC DLG

    TRAUS SUS20

    FDA 510(k)
    FDA Class 2 ·Dental

    REJUVENATE MODULAR STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 2, 2014

    OT PING METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 16, 2012

    RUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015

    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012