3,185 results · 19ms · Sources: EU EUDAMED, US FDA

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Orbera Intragastric Balloon

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

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·INNOVA(TM)VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

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

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD

Transcatheter Septal Occluder

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

Implant, Corneal, Refractive

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

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·NEUGRAFT

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Simplify Cervical Artificial Disc