BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    aprevo® Digital Workflow

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    Exactech, Inc.·10885862659989·Trial, Monobloc Revision Stem

    NA

    FDA UDI
    Exactech, Inc.·10885862282873·TRIAL, MONOBLOC REVISION STEM, 22x195mm

    COAMATIC AT-400

    FDA 510(k)
    FDA Class 2 ·Hematology

    iFuse Bedrock Granite™ Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    STERIS S20 STERILANT

    FDA Adverse Event
    STERIS CORPORATION - HOPKINS·Product code MED·August 24, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    ALINITY I B12

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD·Product code CDD·July 15, 2020

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·September 4, 2009

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 1, 2016

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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