BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Xpert Xpress MVP; GeneXpert Xpress System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELISIO-H HEMODIALYZER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 26, 2011

    IN TOUCH EU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025