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

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    BriefCase

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464011094·HEARLINK 5030 MNR T R BR

    HEALIX ADVANCE

    FDA UDI
    Medos International Sàrl·10886705022441·HEALIX ADVANCE Full Tap Package Contains: 1 Ful...

    CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOJET

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·August 24, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014

    M2A-MAGNUM 42-50M TPR INSRT +6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 12, 2013

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 7, 2025

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 7, 2025

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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