10,000 results · 29ms · Sources: EU EUDAMED, US FDA

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

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

Implantable Pulse Generator

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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ENDURANT II STENT GRAFT SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System with STEEN Solution Perfusate

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, MOMENTUM™ X4, VIGILIANT™, VIGILIANT™ X4