181 results
·
29ms
·
Sources: EU EUDAMED, US FDA
TENDRIL MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·May 15, 2017
TENDRIL MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·May 15, 2017
ASSURITY MRI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·April 20, 2017
ENDURITY MRI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·May 16, 2018
ENDURITY PACEMAKER, DR, MRI RESTRICTED
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·March 17, 2022
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
DCM MAXIM PRIMARY LIPPED BEARING 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 7, 2017
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Endurity MRI ,Assurity MRI Pacemaker
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Tendril MRI leads (MRI)
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI, Endurity MRI family of Pacemakers
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI family of Pacemakers,
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI, Endurity MRI family of Pacemakers
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI, Endurity MRI family of Pacemakers
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Tendril MRI Lead
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI, Endurity MRI
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI Pacemakers
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI, Endurity MRI,Zenex MRI
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI family of Pacemakers
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI, Endurity MRI and Tendril MRI