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

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    IMMULITE BETA-2-MICROGLOBULIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515241473·Hartman Halle Nasal Spec. large, 6"

    K SERIES CPAP SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REFLEX ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROTAINER SST GOLD

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code JKA·June 7, 2018

    BD MICROTAINER® EDTA LAVENDAR TUBES

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code JKA·May 1, 2018

    BD MICROTAINER® EDTA LAVENDAR TUBES

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code JKA·May 16, 2018

    MICROTAINER SST GOLD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD·Product code JKA·May 7, 2018

    BD MICROTAINER® EDTA LAVENDER TUBES

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code JKA·April 27, 2018

    BD MICROTAINER® EDTA LAVENDAR TUBES

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code JKA·May 3, 2018

    BD MICROTAINER® BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code JKA·December 3, 2017

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·June 23, 2014

    ARCHITECT TACROLIMUS

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MLM·January 28, 2013

    LS MICROBR EXT SET

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD·Product code FPA·November 22, 2010

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    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