Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One-Piece Hydrophobic Acrylic Toric Intraoculer Lens (IOL)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony™ OptiBlue™ Extended Range of Vision (ERV) IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MEMORY LENS(R) UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS® Foldable Acrylic IOL with OptiEdge, Model ZA9003

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

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE BLU AND THERAPY COOL BI-DIRECTIONAL ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL ) CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL)

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS MODELS AT50AO AND AT52AO ACCOMMODATING INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SI-18B/SI-18NB UV-ABSORBING SILICONE POSTERIOR IOL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL