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

    Artificial Iris

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·HeartLight Catheter and HeartLight Console

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Neuro Cochlear Implant System

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System

    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Thoraflex Hybrid

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGY MEGATRON Everolimus Eluting Platinum Chromium Coronary Stent System

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire Upper Airway Stimulation

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    FDA Pre-Market Approval
    FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION INTRAOCULAR LENSES (IOLS), MODELS ZXT150, ZXT225,ZXT300, AND ZT375

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

    FDA Pre-Market Approval
    FDA Class 3 ·Covera Vascular Covered Stent

    Femtosecond Laser System For Refractive Correction

    FDA Pre-Market Approval
    FDA Class 3 ·VisuMax Femtosecond Laser

    Stent Graft, Bypass, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·DETOUR System

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER PFO OCCLUDER

    Extended Depth Of Focus Intraocular Lens

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

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify® Cervical Artificial Disc (2 Level)

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·CYPASS SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus 24 Cochlear Implant System

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System