Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ITEC PRELOADED DELIVERY SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL NAVIGATION AND THERMOCOOL BI-DIRECTIONAL CATHETER;THERMOCOOL SF/SF NAV BI-DIRECTIONAL AND SF/SF NAV

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US

Solution, Cleaning / Lubricating, Artificial Eye

FDA classification

FDA Class 3 ·Solution, Cleaning / Lubricating, Artificial Eye

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR & CELSIUS THERMOCOOL CATHETERS

Extended Depth Of Focus Intraocular Lens

FDA classification

FDA Class 3 ·Extended Depth Of Focus Intraocular Lens

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE®II EZ Sterox Bipolar IS-1 Atrial/Ventricular, J shaped Lead Stylets Limber, J shaped Lead Stylets Firm, J shape

Artificial Iris

FDA classification

FDA Class 3 ·Artificial Iris

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser

Phakic Toric Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Visian Toric ICL (IMPLANTABLE COLLAMER LENS)

Ophthalmic Sealant

FDA classification

FDA Class 3 ·Ophthalmic Sealant

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGNRefractive Studio, STAR Excimer Laser System

Phakic Toric Intraocular Lens

FDA classification

FDA Class 3 ·Phakic Toric Intraocular Lens

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM