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

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    LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pathfinder

    FDA UDI
    NEPTUNE MEDICAL INC.·00850006222018·

    LIA-1 Catheter (542-1)

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

    ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    SROM*STM ST,36+8L NK,22X17X165

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code JDI·April 2, 2012

    DUAL EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·May 22, 2014

    3.5FR P.U.R. UMBIL CATH X10

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FOS·October 30, 2012

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·September 23, 2010

    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