BEUDAMED
    10,000 results · 30ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

    Stent, Iliac Vein

    FDA Pre-Market Approval
    FDA Class 3 ·Abre™ Venous Self-expanding Stent System

    Stent, Iliac Vein

    FDA Pre-Market Approval
    FDA Class 3 ·Abre™ Venous Self-expanding Stent System

    Stent, Iliac Vein

    FDA Pre-Market Approval
    FDA Class 3 ·Zilver Vena® Venous Self Expanding Stent

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

    FDA Pre-Market Approval
    FDA Class 3 ·Vivistim System

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·DISCOVISC™ Ophthalmic Viscosurgical Device

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE Transcarotid Stent System

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter

    Transcatheter Septal Occluder

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

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Amulet™ Left Atrial Appendage Occluder

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform”

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS)

    Gases Used Within Eye To Place Pressure On Detached Retina

    FDA Pre-Market Approval
    FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

    Gases Used Within Eye To Place Pressure On Detached Retina

    FDA Pre-Market Approval
    FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

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

    FDA Pre-Market Approval
    FDA Class 3 ·DiamondTemp Ablation System