3,124 results · 18ms · Sources: EU EUDAMED, US FDA

System, Imaging, Fluorescence

FDA Pre-Market Approval
FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR IQ IOL

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·OVATIO DR & OVATIO VR ICDS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG

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, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·CentriMag Circulatory Support System

System, Appendage Closure, Left Atrial

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Rayner C-flex 570C, C-Flex Aspheric 970C and 600C Aspheric Intraocular lenses

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Dexcom G4 Platinum Continuous Glucose Monitoring System and Dexcom 5 Mobile Continuous Glucose Monitoring System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Implantable System for Remodulin

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

FDA Pre-Market Approval
FDA Class 3 ·FlexAbility™ Ablation Catheter, Sensor Enabled™

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval
FDA Class 3 ·Thoraflex Hybrid

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN® Ultrasound Bone Healing System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Carotid Wallstent™ Monorail™ Endoprosthesis

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II CARDIAC ABLATION CATHETHER, STEEROCATH-A CARDIAC ABLATION CATHETER,STEEROCATH-T CARDIAC ABLATION CATHETER