BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    EMS/TENS Massager Device

    FDA 510(k)
    FDA Class 2 ·Neurology

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113646·RETROBULBAR NEEDLE 23GA 38MM

    Pomee

    FDA UDI
    POMEE CORPORATION·G15772330400·Littauer 4 1/2"

    J & J INSTRUMENTS

    FDA UDI
    J & J INSTRUMENTS INC·00817524025781·LITTAUER STITCH SCI 4.5""

    TSI Stem Trial

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215040598·

    LED CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 12, 2024

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 6, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 2, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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