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

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    IMMULITE PAP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RECTANGLE, BLACK COND 10X7X1

    FDA UDI
    ALIMED, INC.·00733657239621·

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515241466·Halle Nasal Spec,32mm blds

    Z5MLB, Z5MLC

    FDA 510(k)
    FDA Class 2 ·Dental

    OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 14, 2014

    PLUM XLM W/MODIFD B

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·November 22, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 28, 2013

    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012