BEUDAMED
    81 results · 28ms · Sources: EU EUDAMED, US FDA

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    Fusion OMNI Sphincterotome

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 29, 2021

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 27, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 1, 2021

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·April 4, 2022

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code KNS·July 19, 2021

    FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·December 13, 2023

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·January 11, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·April 29, 2021

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 20, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 3, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·May 3, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 17, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·June 28, 2021

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·October 11, 2021

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·December 29, 2021

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·October 6, 2021

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·April 5, 2022