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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Celsius, Celsius Flutter, EZ Steer

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FAMILY OF PACEMAKERS