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    OLEA MEDICAL

    FDA registration
    OLEA MEDICAL·3 products·🇫🇷 France

    Olea S.I.A. Neurovascular

    FDA UDI
    Olea Medical USA·EOLENEUROVASV1P00·Olea S.I.A. Neurovascular V1.0 is an optional u...

    Automation Platform

    FDA UDI
    Olea Medical USA·EOLEAUTOMATIONV1P01·The Automation Platform is a software product t...

    Neuro Insight

    FDA UDI
    Olea Medical USA·EOLENEUROINSIGHTV1P00·Neuro Insight V1.0 is an image processing solut...

    MR Diffusion Perfusion Mismatch

    FDA UDI
    Olea Medical USA·EOLEMRDPMV1P00·MR Diffusion Perfusion Mismatch V1.0 is an auto...

    OLEA SPHERE

    FDA UDI
    Olea Medical USA·EOLEOLEASPHEREV3P01·Olea Sphere V3.0 is an image processing softwar...

    Automation Platform V1.5

    FDA UDI
    Olea Medical USA·EOLEAUTOMATIONV1P50·Automation Platform V1.5 is a medical image com...

    MR DWI/FLAIR Measurement

    FDA UDI
    Olea Medical USA·EOLEMRDFMV1P00·MR DWI/FLAIR Measurement V1.0 is an image proce...

    FUNCTIONAL MR

    FDA UDI
    Olea Medical USA·EOLEFMRIV1P00·Functional MR V1.0 is an optional image process...

    CT Perfusion

    FDA UDI
    Olea Medical USA·EOLECTPERFUSIONV1P00·CT Perfusion V1.0 is an automatic calculation t...

    Neurovascular Insight

    FDA UDI
    Olea Medical USA·EOLENEUROVASIV1P00·Neurovascular Insight V1.0 is an optional user ...

    BREASTSCAPE

    FDA UDI
    Olea Medical USA·EOLEBREASTSCAPEV1P00·breastscape V1.0 is an optional image processin...

    Olea S.I.A V1.0

    FDA UDI
    Olea Medical USA·EOLEOLEASIAV1P00·Olea S.I.A V1.0 is a medical image communicatio...

    OLEA SPHERE

    FDA UDI
    Olea Medical USA·EOLEOLEASPHEREV2P31·Olea Sphere V2.3 is an image processing softwar...

    DELTA®

    FDA Adverse Event
    Injury ·MEDTRONIC DOMINICANA·Product code JXG·September 16, 2025

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 12, 2017

    Functional MR V1.0

    FDA Enforcement
    Class II ·Ongoing·OLEA MEDICAL·October 25, 2023

    Functional MR V1.0

    FDA Recall
    Open, Classified ·OLEA MEDICAL 93 AVANUE DU SORBIER, ZONE ATHELIA IV LA CIOTAT France·Product code LLZ·August 10, 2023

    OLSEN

    FDA Adverse Event
    Malfunction ·OLEN MEDICAL CORP·Product code GEI·October 27, 2022

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·August 10, 2023