BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    AI-Rad Companion Brain MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517630599·CoRoent Ant TLIF Ti, 13x12x30mm 15°

    STENTBOOST REL. 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 9, 2022

    PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·October 9, 2020

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 17, 2014

    UNKNOWN DEPUY PINNACLE HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code LPH·August 18, 2011

    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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