Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Volbella XC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify® Cervical Artificial Disc (One-Level)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Supera Peripheral Stent System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheters

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity +, Endurity, Endurity Core

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas® EGFR Mutation Test

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SUPERSTAT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY(R) CARDIAC PACING SYSTEM