10,000 results · 47ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·RelayPro Thoracic Stent-Graft System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Brio Neurostimulation System

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

FDA Pre-Market Approval
FDA Class 3 ·QDOT MICRO™ System

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·ARTISAN/VERISYSE MYOPIA PHAKIC INTRAOCULAR LENS

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·SOLESTA

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

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM

Ring, Endocapsular

FDA Pre-Market Approval
FDA Class 3 ·ALCON REFORM CAPSULAR TENSION RING

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART CALVE WITH PHOSPHOLIPID REDUCTION TREATMENT

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

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE INJECTION GEL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PLATINUM CHRONIUM CORONARY STENT SYSTEM

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid Annular Closure Device

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA Pre-Market Approval
FDA Class 3 ·ASCENSION MCP FINGER IMPLANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA Aesthetic (injectable poly-L Lactic acid)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·X Series Advanced Devices

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart, OPTIMIZER Smart Mini