8,447 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
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
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
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
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT (TIPS, ILIAC, VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE, GORE VIABAHN ENDOPROSTHESIS
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN Left Atrial Appendage CLosure (LAAC) Device with Delivery System