BEUDAMED
    937 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex Artificial Iris

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·SBL-3 Multifocal Intraocular Lens

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP Systems

    Transvenous Temporary Phrenic Nerve Stimulator

    FDA Pre-Market Approval
    FDA Class 3 ·AeroPace® System

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·EVO/EVO+ VISIAN® Implantable Collamer® Lenses

    Reherniation Reduction Device

    FDA Pre-Market Approval
    FDA Class 3 ·Barricaid Anular Closure Device

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED 3 Defibrillator with Uni-Padz

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·ReVision Optics Raindrop Near Vision Inlay

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix Drug Coated Balloon

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Symfony Toric Extended Range of Vision IOLs

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRESTIGE LP Cervical Disc

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire II Upper Airway Stimulator

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems