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

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    Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

    FDA 510(k)
    FDA Class 2 ·Dental

    IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PEDIATRIC CENTRAL VENOUS CATHETER KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 5, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 6, 2026

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC, B.V.·Product code DTB·October 6, 2016

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011

    DAILIES TOTAL 1

    FDA Adverse Event
    Injury ·CIBA VISION GMBH·Product code MVN·October 29, 2014

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 12, 2013

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 21, 2025

    CONTOUR® NEXT

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

    CONTOUR® PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 3, 2025

    CONTOUR® PLUS ELITE

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

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025