BEUDAMED
    657 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Tissue Adhesive Internal Use

    FDA Pre-Market Approval
    FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

    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, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·WRAPSODY Cell-Impermeable Endoprosthesis

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·FARAPULSE Pulsed Field Ablation System

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·AGENT Paclitaxel-Coated Balloon Catheter

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·CraniSeal Dural Sealant

    Pulmonary Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

    Tricuspid Valve Repair Device, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·TriClip™ G4 System

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    FDA Pre-Market Approval
    FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

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

    FDA Pre-Market Approval
    FDA Class 3 ·WRAPSODY Cell-Impermeable Endoprosthesis

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify Cervical Artificial Disc

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·TactiFlex™ Ablation Catheter, Sensor Enabled™

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable

    Stent Graft, Infrapopliteal, Venous Arterialization

    FDA Pre-Market Approval
    FDA Class 3 ·LimFlow System

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Solia S Leads

    Implant, Anti-Gastroesophageal Reflux

    FDA Pre-Market Approval
    FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·DIASORIN ETI-AB-AUK PLUS ASSAY