Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Device Command Library (DCL), CareLine Express

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Instrument Command Library (ICL), Device Command Library (DCL)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Reactiv8 Implantable Neurostimulation System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Telemetry Wand

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Intellis Spinal Cord Stimulation Systems

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Perfluoron

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL 5000

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLUORON

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Silikon 1000