Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System and HFX iQ System

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Single Piece Intraocular Lenses

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR IOLS +3.0 D & +4.0 D ADD POWERS

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ SINGLE-PIECE IOL WITH THE ACRYSERT C DELIVERY SYSTME

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Acrysof IQ Aspheric UV absorbing IOL with the UltraSert Pre-Loaded Delivery System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TORIC LENS BENCH WITH RENISHAW GAUGE ACRYSOF TORIC & ACRYSOF IQ INTRAOCULAR LENSES

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS