10,000 results · 27ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Implant, Corneal, Refractive

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

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·MEL 90 EXCIMER LASER SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision WaveWriter Spinal Cord Stimulator (SCS) System / WaveWriter IPG Test Equipment System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval
FDA Class 3 ·EVOQUE Tricuspid Valve Replacement System

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·VISULAS 690S LASER AND VISULINK PDT ADAPTER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed™ 630G System with SmartGuard™

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MemoryGel® BOOST™ Silicone Gel-Filled Breast Implant

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

FDA Pre-Market Approval
FDA Class 3 ·Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CT Lucia 602

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM