573 results
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26ms
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Sources: EU EUDAMED, US FDA
QUADRA ASSURA MP ICD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NIK·June 3, 2016
QUADRA ASSURA MP ICD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NIK·June 22, 2016
UNIFY ASSURA ICD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NIK·March 15, 2017
UNIFY ASSURA ICD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC·Product code NIK·January 10, 2017
GALLANT HF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NIK·February 20, 2023
UNIFY ASSURA DDQP+
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NIK·November 16, 2015
UNIFY QUADRA MP ICD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code NIK·January 13, 2017
QUADRA ASSURA DDQP+
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NIK·November 22, 2017
UNIFY ASSURA DDQP+
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NIK·June 28, 2016
GALLANT HF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NIK·May 30, 2023
QUADRA ASSURA MP ICD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NIK·February 9, 2018
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code OJX·May 7, 2022
QUADRA ASSURA DDQP+
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NIK·August 16, 2018
QUICKSITE LV
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVY·January 28, 2020
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ST JUDE MEDICAL EPIC HF SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·QuickFlex u, Quartet
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EPIC HF/ATLAS+ HF FAMILY OF CRT-DS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILY OF CRT-DS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EPIC HF/ATLAS+ FAMILY OF CRT-DS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ST JUDES MEDICAL ICDS AND CRT-DS