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 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

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 ·AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Element Plus Everolimus-Eluting Plaatinum Chromium Coronary Stent System (Monorail and Over-the-Wire), PROMUS PRE

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type-1 System

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·LifeStream Balloon Expandable Vascular Covered Stent

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate 4000 System