Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Synvisc, Synvisc-One

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM ADHESION BARRIER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Silikon 1000

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC (HYLAN G-F 20

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Glaukos Corporation iStent Trabecular Micro-Bypass Stent System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM FAMILY OF NEUROSTIMULATION LEADS

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Onyx Liquid Embolic System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Lidocaine Dermal Filler