Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERGEL ADHESION PREVENTION SOLUTION

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

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VICI VENOUS STENT System and VICI RDS Stent System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Genesis Neurostimulation System

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

FDA Pre-Market Approval

FDA Class 3 ·GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·WET-N-SOAK(TM) REWETTING DROPS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Medstream Programmable Infusion Pump System

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) REWETTING DROPS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LC-65 (R) DAILY CONTACT LENS CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·WET-N-SOAK

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ULTRA CARE (TM) NEUTRALIZING TABLET

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Synergy™ IOL with TECNIS Simplicity® Delivery System, TECNIS Synergy™ Toric II IOL with TECNIS Simplicity® Delive

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS-WET(TM)