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

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    BB 8 Sinus Dilation Kit

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120694·Guidewire 2.5x230mm Partially Thrd

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120687·Guidewire 2.5x230mm Sgl Trocar

    FIRST RESPONSE PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Edwards eSheath Introducer Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EDWARDS ESHEATH+ INTRODUCER SET

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022

    UNKNOWN EDWARDS TRANSFEMORAL SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026

    TF SHEATH UNKNOWN

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023

    UNKNOWN EDWARDS LIFESCIENCES SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 7, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    ESHEATH INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021

    UNKNOWN EDWARDS LIFESCIENCES SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 30, 2024

    UNKNOWN EDWARDS INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023

    EDWARDS TRANSFEMORAL SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022

    UNKNOWN EDWARDS INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023