BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011

    PERMANENT CAUTERY HOOK INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·August 22, 2008

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·November 23, 2022

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023