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

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK

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

    FDA Pre-Market Approval
    FDA Class 3 ·Arctic Front and Arctic Front Advance Cardiac CryoAlbation Catheters

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Avant™ VR, Neutrino™ NxT VR, Gallant™ VR, Entrant™ VR, Avant™ DR, Neutrino™ NxT DR, Gallant™ DR, Entrant™ DR

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic Evolut R Transcatheter Aortic Valve Replacement System, Medtronic Evolut PRO Transcatheter Aortic Valve Replac

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·ORBERA Intragastric Balloon

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM AFP (LN 7A48)

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS

    Lenses, Soft Contact, Extended Wear

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

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VISCOAT/DUOVISC Ophthalmic Viscoelastic System

    Somatic Gene Mutation Detection System

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·PERLANE L INJACTABLE GEL

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs)

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer Muscular VSD Occluder

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS INTUITY Elite Aortic Valve

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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