Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE PRO RX Nitinol Stent System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses.

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SMART AND SMART CONTROL VASCULAR STENT SYSTEMS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SMART CONTROL NITINOL STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·TRYTON Side Branch Stent

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·BINKHORST & FEDOROV I IRIS CLIP IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·4Kscore Test

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip Vascular Closure Device

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAPSCOPE 550

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cordis® EXOSEAL® Vascular Closure Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM