8,447 results · 24ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDR0PROSTHESIS WITH HEPARIN BIOACTIVE SURFAC, GORE VIABAHN ENDOPROTHESIS

Stent, Superficial Femoral Artery

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

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT (TIPS/LLIAC/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

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·WALLSTENT (TIPS AND VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter (AUS) with and without InhibiZone™

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR

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 ·GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface