BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    AO FLEXIBLE LARYNGOSCOPE, #LS-7

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002658·VITROS Chemistry Products DAT Performance Verif...

    ACUMED

    FDA UDI
    Acumed LLC·10806378097614·2.0mm Locking Drill Guide/2.3mm Screws

    PROFILE-ER

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MAGNETOM C!

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 5, 2007

    SCRW,2.4X14MM CANCELOUS LOCKNG

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·October 24, 2012

    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 14, 2018

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015