BEUDAMED
    10,000 results · 48ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

    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 EXCLUDER AAA ENDOPROSTHESIS

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·GORE TIGRIS Vascular Stent

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

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

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

    Shunt, Portosystemic, Endoprosthesis

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

    Stent, Superficial Femoral Artery

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

    Stent, Superficial Femoral Artery

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Covera™ Vascular Covered Stent

    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

    System, Endovascular Graft, Aortic Aneurysm Treatment

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

    Artificial Heart

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

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Bard E-LUMINEXX and LIFESTAR Vascular Stents

    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, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

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