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MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ST. JOSEPH HSP BALTIMORE MD1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

SMART, PERFUSION PACKS, CONNECTORS, TUBING

FDA Adverse Event
Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023

CSC14 CARDIOLOGIA HEAT EXCHANGER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTR·March 10, 2016

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTR·November 20, 2015

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

everX Flow

FDA UDI
Gc America Inc.·D0470128981·everX Flow, Bulk Shade

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304133048·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304132881·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304132928·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304133024·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304132843·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304133000·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304132980·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304132904·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304132966·