BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    FUJITSU MALLEABLE - TIP BRAIN SPATULA

    FDA 510(k)
    FDA Class 1 ·Neurology

    HIGHPAK-12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 8, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·December 10, 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