BEUDAMED
    123 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·xT CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·xT CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·xT CDx

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx®

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cologuard

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Gore Helex Septal Occluder, Gore CardioForm Septal Occluder

    System, Endovascular Graft, Aortic Aneurysm Treatment

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

    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

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Gore Viatorr Tips Endoprosthesis; Gore Viatorr Tips Endoprosthesis with Controlled Expansion

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprsthesis

    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, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·MICRA TRANSCATHETER PACING SYSTEM