13 results · 26ms · Sources: EU EUDAMED, US FDA

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PLASMACELL-C DISPOSABLE KIT W/ ATTACHED FISTULA

FDA Adverse Event
Death ·FENWAL, INC.·Product code GKT·October 29, 2009

FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·November 24, 2025

AMICUS SEPARATOR SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·December 14, 2018

AMICUS SEPARATOR SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code LKN·September 6, 2023

AURORA PLASMAPHERESIS SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·October 28, 2021

AMICUS SEPARATOR SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·September 1, 2021

AURORA XI PLASMAPHERESIS SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·June 9, 2023

PLASMACELL XI DISPOSABLE SET WITH SPIKESMART

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·October 14, 2024

PLASMACELL XI DISPOSABLE SET WITH SPIKESMART

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·June 25, 2025

PLASMACELL XI DISPOSABLE SET WITH SPIKESMART

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·May 9, 2025

FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·May 19, 2025

FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·February 23, 2026

AMICUS SEPARATOR SYSTEM

FDA Adverse Event
Death ·FENWAL INTERNATIONAL INC.·Product code GKT·February 23, 2022