Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HOYA iSert 250/251 and Clarisert Pre-Loaded IOL Injector System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXE-ELUTING CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE LOADED DELIVERY SYSTEM MODELS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·MORCHER® EYEJET® CTR Single-Use Injector

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·MORCHER® Capsular Tension Rings

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·RINGJECT