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

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    Tens & Ems Device (TU1080)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IS 40 MICROMOTOR

    FDA 510(k)
    FDA Class 1 ·Dental

    Zimmer Persona Personalized Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOUR® PLUS BLUE

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

    GORE® HYBRID VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·November 11, 2014

    UNIFY CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2011

    M2A 1 PC SHELL 38MMX56MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 23, 2013

    CONTOUR® CARE

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

    CONTOUR® CARE

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

    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    CONTOUR® NEXT

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

    CONTOUR® PLUS ELITE

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