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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·CERAMAX CERAMIC HIP SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Puregraft Serene Breast Implant

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Oxford Partial Knee System

Valve, Pulmonary

FDA Pre-Market Approval
FDA Class 3 ·Spiration Valve System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·IsoMed Infusion System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring (CGM) System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LVAS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE Transcarotid Stent System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PC-58NBM & PC-58NBZ IOLS