1,907 results · 21ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

System, Endovascular Graft, Aortic Aneurysm Treatment

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

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Artificial Heart

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

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 ·GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM ASD Occluder

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

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

Stent, Superficial Femoral Artery

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

Stent, Superficial Femoral Artery

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

Artificial Heart

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

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Bard E-Luminexx and LifeStar Vascular Stent

System, Hemodynamic, Implantable

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

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS