BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    PAL Multi-Use Cannulas and PAL Manual Wand

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QUASAR CALYPSO

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025

    CONTOUR® XT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

    POWERLINK SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·June 14, 2013

    SYNVISC HYLAN G-F 20

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY·Product code MOZ·July 14, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 14, 2014

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026

    CONTOUR® XT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·December 3, 2024

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

    CONTOUR® PLUS

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 4, 2025

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026