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    PAQ.112X100X300/QI-HS/GOLDWAY

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763008637·

    REFLEX CATHETER

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·April 15, 2024

    SOLITAIRE RD

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 15, 2024

    AVAIRA TORIC (ENFILCON A)

    FDA Adverse Event
    Injury ·COOPERVISION CARIBBEAN CORP.·Product code LPL·December 14, 2012

    DAILIES TOTAL 1

    FDA Adverse Event
    Injury ·CIBA VISION GMBH·Product code MVN·April 16, 2014

    BRAINLAB ELEMENTS 6.0;ELEMENTS IMAGE FUSION;ELEMENTS IMAGE FUSION ANGIO;ELEME

    FDA Adverse Event
    Injury ·BRAINLAB AG·Product code QIH·July 29, 2024

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    FDA Adverse Event
    Malfunction ·BRAINLAB AG·Product code QIH·August 13, 2025

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    FDA Adverse Event
    Malfunction ·BRAINLAB SE·Product code QIH·April 9, 2026

    ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT)

    FDA Adverse Event
    Malfunction ·BRAINLAB AG·Product code QIH·December 23, 2024

    BRAIN LAB IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·BRAINLAB AG·Product code QIH·June 2, 2025

    SONIO DETECT

    FDA Adverse Event
    Malfunction ·SONIO·Product code QIH·June 25, 2025

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    FDA Adverse Event
    Malfunction ·BRAINLAB AG·Product code QIH·May 2, 2025

    ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT)

    FDA Adverse Event
    Malfunction ·BRAINLAB AG·Product code QIH·January 17, 2025

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    FDA Adverse Event
    Malfunction ·BRAINLAB SE·Product code QIH·February 26, 2026

    SOLITAIRE RD

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 15, 2024

    REFLEX CATHETER

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·April 15, 2024

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code LPN·June 29, 2006

    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

    FDA Recall
    Terminated ·Caption Health·Product code QIH·May 19, 2021

    Automated Radiological Image Processing Software

    FDA classification
    FDA Class 2 ·Automated Radiological Image Processing Software

    Amvex Vacuum Regulator

    FDA UDI
    OHIO MEDICAL, LLC·00628101501044·VR-CI series, VacReg, Cont Int 300mmHg, Ohio A...