BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    WellsForm Tricuspid Annuloplasty Band (WF)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464029099·HEARLINK 9030 MNR T BL/DG DEMO

    Automatic Registration

    FDA 510(k)
    FDA Class 2 ·Neurology

    MAS LIPID LEVEL 1 AND 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    CONTOUR® PLUS BLUE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 6, 2014

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 17, 2011

    TOTAL ASR FEM IMP SIZE 57

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 16, 2013

    CONTOUR® PLUS BLUE

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

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 13, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    CONTOUR® CARE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 7, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026