321 results · 23ms · Sources: EU EUDAMED, US FDA

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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