1,907 results · 20ms · Sources: EU EUDAMED, US FDA

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·FREEDOM DRIVER SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·Beta-Cath System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2030, HX2035

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·BETA-CATH (TM) SYSTEM

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS I3 Patient Electronics System (PES)

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

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

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

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG Thoracic Endoprosthesis

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Gore Tag Thoracic Endoprosthesis

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·Ventana PD-Ll (SP263) Assay

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART