Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-Piece IOL with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal IOL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS OptiBlue 1-Piece IOL, TECNIS OptiBlue Monofocal 1-Piece with Smart LOAD Delivery Technology, TECNIS 1-Piece OptiB

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Avive Automated External Defibrillator (AED) System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Hancock Modified Orifice Valved Conduit

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SUPERSTAT

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL MRI

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·Esprit BTK Everolimus Eluting Resorbable Scaffold System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL U58OH POSTERIOR CHAMBER LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM IPG/ETS 3.0

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER VISIAN IMPLANTABLE COLLAMER LENS MICL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME EECSS(XIENCE PRIME AND XIENCE PRIME LONG LENGTHS)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·DERMAGRAFT-TC(TM)