BEUDAMED
    53 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Trifecta™ Valve with Glide Technology™

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ELCA Coronary Atherectomy Catheters

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Portico™

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Myopore® Sutureless Myocardial Pacing Lead

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Brio Neurostimulation System

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Axium Neurostimulator System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Genesis Neurostimulation System

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy Systems

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) System

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Deep Brain Stimulation Therapy System for Parkinson's Disease

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Onyx Liquid Embolic System

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM (LES)

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Onyx™ Liquid Embolic System

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Apollo™ Onyx™ Delivery Micro Catheter