Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·NOVATION CERAMIC ARTICULATION HIP SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CHECKMATE SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COSTASIS SURGICAL HEMOSTAT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P12 MODEIFIED C LOOP W/NOTCH POSTERIOR CHAM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL VASCULAR CLOSURE DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL vascular Closure Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic 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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES