10,000 results · 49ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis with InhibiZone™

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter with InhibiZone™

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·ORTHOVISC HIGH MODECULAR WEIGHT HYALURNAN

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Akreos Posterior Chamber Intraocular Lens

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ORIGEN ICD, INOGEN ICD, DYNAGEN ICDS

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval
FDA Class 3 ·LUMBAR I/F CAGE WITH VSP SPINE SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Intuity Elite Valve System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis (Resilia tissue)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier - Edwards Perimount Magna East Pericardial Aortic Bioprosthesis with ThermaFix tissue process

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Progel Pleural Air Leak Sealant (Progel™ PALS)

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·RIGID GAS PERMEABLE CONTACT LENS

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Tridyne Vascular Sealant (Tridyne™ VS)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Sculptra®

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·Esteem System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers