368 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx®
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EZTRK 2, ACUITY SPIRAL, ORIGEN CRT-D, INOGEN CRT-D, DYNAGEN CRT-D, NAV 2 QUADPOLE, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, VI
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Fluency® Plus Endovascular Stent Graft
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·FLAIR ENDOVASCULAR STENT GRAFT
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·BARD FLAIR ENDOVASCULAR STENT GRAFT
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Fluency Endovascular Stent Graft