Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX AND MODELS 7200TFX

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RADIUS CORONARY STENT WITH DELIVERY SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL NT HEMOSTATIC MATRIX

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM/SPINAL-STIM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·INSPIRE II UPPER AIRWAY STIMULATION SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Ascending Aortic Prosthesis

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment

Tissue Adhesive Internal Use

FDA Pre-Market Approval

FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT AND FLEXTIP APPLICATORS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Evoke® SCS System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SKINVIVE™ by Juvederm

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·INSTAT COLLAGEN HEMOSTAT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PROMRI ICD/CRT-D SYSTEM