BEUDAMED
    10,000 results · 46ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify Disc

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm® Volux™ XC

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Microny

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·CentriMag™ Circulatory Support System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Ethos AquaTech Monthly, Ethos AquaTech Monthly for Astigmatism, Ethos AquaTech Monthly Multifocal

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System with Enlite Sensor

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

    FDA Pre-Market Approval
    FDA Class 3 ·Praxis Extended RAS Panel

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

    FDA Pre-Market Approval
    FDA Class 3 ·EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THERMOCOOL NAV

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·HEALON ENDOCOAT OPTHALMIC VISCOSURGICAL DEVICE

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE FAMILY ICDS

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE MVP Venous Vascular Closure System (VVCS)