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

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    Reach Needle

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EarQ

    FDA UDI
    Sbo Hearing A/S·05714464053537·EARQ F20 MINIRITE R C092

    EASY MED TN-28 C

    FDA 510(k)
    FDA Class 2 ·Neurology

    MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 13, 2021

    INTERLINK CATHETER EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 24, 2008

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·September 9, 2011

    1.2MM DIAMOND BALL, EXT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    DENALI JUGULAR SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023

    DENALI JUGULAR SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

    DENALI JUGULAR SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023