Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Coronary Stent System

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE Pulsed Field Ablation System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer UV Absorbing Posterior Chamber Three and One Piece Foldable Intraocular LEns

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/995CS/995MS

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT® AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

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 ·HeartMate 3™ Left Ventricular Assist System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS MULTIFOCAL SILICONE IOL/MODEL ZM900 & THE TECNIS MULTIFOCAL FOLDABLE ACRYLIC IOL MODEL ZMA00

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Navistar Thermocool Deflectable Diagnostics/Ablation Catheter

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus Microstent