17 results · 49ms · Sources: EU EUDAMED, US FDA

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IRRAFLOW

FDA Adverse Event
Malfunction ·IRRAS USA, INC·Product code GWM·May 21, 2021

IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM

FDA Adverse Event
Malfunction ·IRRAS USA INC·Product code GWM·August 11, 2023

IRRAFLOW

FDA Adverse Event
Injury ·IRRAS USA INC.·Product code JXG·September 18, 2023

IRRAS

FDA Adverse Event
Death ·IRRAS USA, INC.·Product code JXG·September 21, 2025

IRRAS

FDA Adverse Event
Malfunction ·IRRAS USA, INC.·Product code GWM·December 21, 2021

IRRAFLOW CATHETER 2.0

FDA Adverse Event
Malfunction ·IRRAS USA, INC.·Product code GWM·December 21, 2021

IRRAFLOW SYSTEM TUBE SET CASSETTE

FDA Adverse Event
Malfunction ·IRRAS USA INC.·Product code GWM·March 27, 2023

IRRAFLOW SYSTEM

FDA Adverse Event
Malfunction ·IRRAS USA INC.·Product code GWM·April 3, 2023

IRRAFLOW CATHETER

FDA Adverse Event
Injury ·IRRAS USA, INC.·Product code JXG·November 7, 2023

IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM CONTROL UNIT 4.0

FDA Adverse Event
Malfunction ·IRRAS USA INC.·Product code GWM·December 5, 2022

IRRAFLOW

FDA Adverse Event
Other ·IRRAS USA, INC.·Product code GWM·October 16, 2024

IRRAFLOW

FDA Adverse Event
Other ·IRRAS USA, INC.·Product code JXG·October 16, 2024

IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM

FDA Adverse Event
Injury ·IRRAS USA INC.·Product code JXG·October 16, 2023

IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM

FDA Adverse Event
Injury ·IRRAS USA INC·Product code GWM·April 4, 2023

IRRAFLOW

FDA Adverse Event
Malfunction ·IRRAS USA, INC.·Product code GWM·January 26, 2022

IRRAFLOW

FDA Adverse Event
Malfunction ·IRRAS USA, INC.·Product code GWM·January 11, 2022

HUMMINGBIRD

FDA Adverse Event
Malfunction ·IRRAS USA, INC.·Product code GWM·January 26, 2022