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Sources: EU EUDAMED, US FDA
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Spiral Laboratories
FDA UDI
SOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUES·00199874508153·Analyzer, chemistry (photometric, discrete), fo...
SORIN S5 BUBBLE DETECTOR
FDA Adverse Event
SORIN GROUP DEUTSCHLAND·Product code KRL·October 7, 2016
SORIN S5 BUBBLE DETECTOR
FDA Adverse Event
SORIN GROUP DEUTSCHLAND·Product code KRL·October 13, 2016
SORIN S3 BUBBLE DETECTOR SENSOR
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code KRL·December 6, 2016
SORIN S3 BUBB DET SENSOR, LOW LEVEL II
FDA Adverse Event
SORIN GROUP DEUTSCHLAND·Product code KRL·September 30, 2015
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code KRL·February 13, 2009
CAPIOX BUBBLE TRAPS
FDA Adverse Event
Malfunction
·TERUMO CORP., ASHITAKA·Product code KRL·June 10, 2010
CAPIOX BUBBLE TRAPS
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code KRL·June 10, 2010
SHILEY HEART LUNG MACHINE
FDA Adverse Event
Death
·SORIN BIOMEDICAL, INC.·Product code KRL·August 8, 1996
BUBBLE DETECTOR
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·April 6, 2022
BUBBLE DETECTOR SENSOR
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·June 16, 2022
BUBBLE DETECTOR SENSOR
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·May 6, 2022
BUBBLE TRAP HOLDER
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code KRL·January 11, 2012
SARNS 8000 MODULE PERFUSION SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code KRL·October 27, 2017
BUBBLE SENSOR DETECTOR
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·February 17, 2023
BUBBLE SENSOR DETECTOR
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·February 17, 2023
TERUMO AIR BUBBLE DETECTOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KRL·October 17, 2007
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KRL·October 15, 2009
BUBBLE DETECTOR SENSOR
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·July 14, 2023
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KRL·May 28, 2009