BEUDAMED
    13 results · 39ms · Sources: EU EUDAMED, US FDA

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    OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000

    FDA Recall
    Open, Classified ·NeuroLogica Corporation·Product code JAK·June 6, 2023

    Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code IZL·May 6, 2019

    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code IZI·September 14, 2015

    The GC80 Digital X-ray Imaging System

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code KPR·June 22, 2017

    Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code KPR·May 24, 2017

    WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code IYN·July 25, 2019

    GM60A. Digital Diagnostic Mobile X-Ray System.

    FDA Recall
    Open, Classified ·NeuroLogica Corporation·Product code IZL·July 8, 2024

    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code IYN·July 25, 2019

    GM85 Digital Mobile X-ray imaging System; Model Number: GM85;

    FDA Recall
    Open, Classified ·NeuroLogica Corporation·Product code IZL·October 7, 2025

    OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code JAK·July 15, 2020

    Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

    FDA Recall
    Open, Classified ·NeuroLogica Corporation·Product code IZL·March 8, 2023

    Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

    FDA Recall
    Open, Classified ·NeuroLogica Corporation·Product code IZL·December 28, 2023

    Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

    FDA Recall
    Terminated ·NeuroLogica Corporation·Product code MQB·January 12, 2018