1,116 results · 19ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II/BLAZER II XP CARDIAC ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER PRIME XP CARDIAC ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY DUAL 8 CARDIAC ABLATION SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL), (UNI-DIRECTIONAL)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·MetriQ Pump

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·VISITAG SURPOINT External Processing Unit (EPU)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER THERMOCOOL NAVIGATION AND THERMOCOOL BI-DIRECTIONAL CATHETER;THERMOCOOL SF/SF NAV BI-DIRECTIONAL AND SF/SF NAV

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval
FDA Class 3 ·REPEL-CV

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path SP Ablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path Duo and Therapy Cool Flex

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY DUAL 8 ABLATION CATHETER, THERAPY 8 MM THERMISTOR , SAFIRE TX ABLATION CATHETERS & GENERATORS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EGFR Mutation Test, v2.0

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER™ OPEN-IRRIGATED Ablation Catheter, INTELANAV™ OPEN-IRRIGATED Ablation Catheter, INTELLANAV MIFI™ OPEN-IRRIGATED A

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit