BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    Axial3D Cloud Segmentation Service

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BBL™ Sensi-Disc™ Cefotaxime 30 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902316078·BD BBL™ Sensi-Disc™ Cefotaxime 30 µg

    BLACKHAWK Cervical Spacer System

    FDA UDI
    Choice Spine, LP·00840996164733·BLACKHAWK,STERILE,CONVEX,16X14X7

    ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    Eclipse Treatment Planning System v16.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMP,TSV,MCOL MG,4.1MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 12, 2021

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 7, 2019

    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 6, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 1, 2011

    URETEX SUPPORT PP HALO NEEDLE KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·July 12, 2013

    IMP,TSV,MCOL MG,4.1MM,8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 17, 2022

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

    BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607; 5 ug, Catalog No. 291308

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024