321 results
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23ms
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Sources: EU EUDAMED, US FDA
MAESTRO 4000 CONTROLLER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LPB·April 25, 2023
MAESTRO FOOT SWITCH
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OAD·September 6, 2018
MAESTRO 4000 CONTROLLER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LPB·September 29, 2025
MAESTRO 4000 CONTROLLER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LPB·November 3, 2023
MAESTRO 4000 CONTROLLER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OAD·September 7, 2023
MAESTRO 4000 POD, 100W
FDA Adverse Event
Malfunction
·STELLARTECH RESEARCH CORPORATION·Product code LPB·August 17, 2023
MAESTRO 4000 CONTROLLER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LPB·October 2, 2023
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Intella Tip MiFi XP cardiac ablation catheters
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer II XP Cardiac Ablation Catheter and Cable
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Maestro 4000 Controller
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer II, Blazer II HTD, Blazer II XP, Blazer Prime HTD, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav MiFi XP, Intel
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Tempera
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·INTELLA TIP MIFI XP ABLATION CATHETER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro)
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND ACCESSORIES AND MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·INTELLATIP MIFI FILTER MODULE, INTELLATIP MIFI REFERENCE CABLE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer II XP Catheter, Blazer Prime XP Catheter, IntellaTip MiFi XP Catheter, IntellaNav XP Catheter and IntellaNav MiFi
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·EP TECH EPT-1000XP RF ABLATION SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES