BEUDAMED
    44 results · 26ms · Sources: EU EUDAMED, US FDA

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    Signia sterilization tray

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITEK 2 GRAM POSITIVE VRSA SCREEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MAGNETOM AERA; MAGNETOM SKYRA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

    HYPODERMIC NEEDLE PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FMI·September 25, 2006

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·June 11, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code NIQ·September 12, 2008

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·April 20, 2026

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·April 17, 2026

    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

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·April 3, 2026

    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

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·April 24, 2026

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Injury ·MICROVENTION INC.·Product code KRD·January 14, 2025

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code HCG·May 28, 2026

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·October 16, 2024

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION INC.·Product code KRD·September 15, 2024

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Injury ·MICROVENTION, INC·Product code HCG·May 2, 2024

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVERSION, INC.·Product code KRD·February 28, 2024