BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    VENTI-SCAN II

    FDA 510(k)
    FDA Class 2 ·Radiology

    A1AT Genotyping Test

    FDA 510(k)
    FDA Class 2 ·Immunology

    DROPPER, CEPTI-SEAL LAVTOPHENOL

    FDA 510(k)
    FDA Class 1 ·Pathology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    FLEXICAP DISCONNECT CAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 16, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020