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

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    OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RAICHEM(TM) SPIA(TM) IGM REAGENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONTINUUM SHELL WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LZO·March 5, 2013

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Other ·DEXCOM, INC.·Product code MDS·February 1, 2011

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·July 23, 2014

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 25, 2023

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 2, 2024

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·Product code FWM·August 17, 2021

    Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 12, 2025