Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOF-FORM 55 EW AND LL-55 SOFT HYDROPHILIC SPHERICAL CONTACT LENSES

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART CONTROL NITINOL STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE AND PRECISE RX NITINOL STENT SYSTEMS

Pulmonary Stent

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. RADIANZ Vascular Stent System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RelayPro Thoracic Stent-Graft 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 (SENOFILCON A) BRANDED CONTACT LENSES.

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Cordis® PALMAZ® Balloon-Expandable Stent

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

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

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36