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

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    CPK ISOENZYME REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CURITY PEAKOMETER

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

    MEGAFIX® Pedicle Screw Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·June 2, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 6, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 15, 2012

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. - HUNTINGTON·Product code MFK·May 22, 2015

    ACCOLADE SR SL MRI (Model L310)

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