System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO Abdominal Stent-Graft System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL(R) OSMOSTIC CERVICAL DILATOR

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CORDIS EXOSEAL VASCULAR CLOSURE DEVICE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SMART CONTROL NITINOL STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·CORDIS S.M.A.R.T. CONTROL NITINOL STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE )

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Cordis PRECISE Nitinol Stent System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Cordis® PRECISE® Nitinol Stent Systems