10,000 results · 40ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICK-CLOSE VASCULAR SUTURING SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·OPTISENSE MODEL 1699T/TC LEADS

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·ANGELCHIK ANTI-REFLUX PROSTHESIS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL FAMILY OF LEADS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Solesta Injectable Gel

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PARAGON & PHOENIX PACEMAKERS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BIOSENSE WEBSTER CABLES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Ventricular (Assist) Bypass

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HiResolution Bionic Ear System

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Aptima HPV Assay

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Touch Dispenser