Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Talisman™ PFO Occluder

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER PFO OCCLUDER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

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

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS-WET(TM)

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·FRED

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·LVIS

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval

FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval

FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate