Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000 SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER MX2 CORONARY STENT SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S2 AND S3 EXCIMER LASER SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC 1-PEICE INTRAOCULAR LENS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS 217A EXCIMER LASER SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

FDA classification

FDA Class 3 ·Whole Blood Pre-Treatment T-Cell Enrichment Reagent

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM