919 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Thermocool Smarttouch SF Uni-directional Catheter, Thermocool Smarttouch SF Uni-directional Catheter
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·QIAGEN THERASCREEN EGFR RGQ PCR KIT
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II XP ABLATION CATHETERS, INTELLATIP MIFI XP ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES ASSOICATED WITH CARDIAC
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS 4800 BRAF V600 MUTATION TEST
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·IntellaNav MiFi XP Ablation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Ampere Generator, Ampere Remote Control, Ampere Generator System Kit
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·IntellaNav MiFi XP, IntellaNav XP
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES, AND BLAZER II XP, BLAZER PRIME XP ABLATION CATHETERS
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Therapy Dual 8 and Therapy 8mm Tip Thermistor Ablation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Therapy Cool Path Duo Ablation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERAPY COOL PATH ABLATION CATHETERS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer Open Irrigated Temperature Ablation Catheter
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THXID-BRAF KIT
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EPT-1000XP CARDIAC ABLATION SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat CDx FLT3 Mutation Assay