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

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    KVM HEMOGLOBIN LYSING REAGENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    HOFMANN KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIPOLAR HIP DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·June 12, 2014

    COBAS INTEGRA 400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 27, 2010

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·December 21, 2012

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 15, 2021

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·January 27, 2022

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014