61 results
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30ms
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Sources: EU EUDAMED, US FDA
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TX eco EXT Cable
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TX eco Extension Cable
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO System, nGEN Generator
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT Micro Uni-Directional Navigation Catheter, QDOT Micro Bi-Directional Navigation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO Navigation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO Uni-Directional Navigation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT Micro Navigation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO Catheter, Interface Cables
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO Uni-Directional Navigation Catheter, QDOT MICRO Bi-Directional Navigation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·QDOT MICRO System
QDOT MICRO
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code OAE·May 27, 2026
QDOT MICRO
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code OAE·April 28, 2026
QDOT MICRO
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code OAE·May 19, 2026
NGEN RF GENERATOR
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code OAE·December 16, 2025