937 results · 21ms · Sources: EU EUDAMED, US FDA

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

System, Appendage Closure, Left Atrial

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

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Lotus Edge Valve System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·FRED X System

Prosthesis, Posterior Spinal Elements

FDA Pre-Market Approval
FDA Class 3 ·TOPS™ System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE LP CERVICAL DISC

Stimulator, Hypoglossal Nerve, Implanted, Apnea

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

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 780G System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·TRYTON Side Branch Stent

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re

Ventricular (Assist) Bypass

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