Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PreVue Pre-loaded System, IPURE Pre-loaded System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Bulkamid Urethral Bulking System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800TM URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 TM INFLATABLE PENILE PROSTHESIS(IPP) WITH INHIBIZONE TREATMENT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded IOL System, Intraocular Lens - Clarisert

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISPHERIC MODEL YA-60BB INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LIMULUS AMEBOCYTE LYSATE BACTERIA TEST

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSymm, iSpheric IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT PY-60AD

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT MODEL PC-60AD PACKAGING IMPROVEMENT