10,000 results · 28ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ONE PIECE (NON-CM) TM POSTERIOR CHAMBER LENSES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLUMA XC

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS ACRYLIC IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS MODEL 305

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AKREOS INTRAOCULAR LENS,MODEL AO60 and MI60L

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCADE 6/7f VCS & VASCADE 5F VCS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDESIGN Refractive Studio; STAR Excimer Laser System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Cerene Cryotherapy Device

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Wave Writer Alpha™ Spinal Cord Stimulator (SCS) System, Spectra Wave Writer™ Spinal Cord Stimulator (SCS) System, Precis

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STYLE UV40 POSTERIOR CHAMBER LENS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION & ML8 CORONARY STENT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·INAMED SILICONE-FILLED BREAST IMPLANTS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Ablation Catheter (including Bi-Directional Catheter) Therapy 4mm Thermistor Ablation Catheter

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Apollo Onyx Delivery Micro Catheter

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·DURATA FAMILY OF HIGH VOLTAGE LEADS