Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·STAT-PACE II ESOPHAGEAL PACING SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·NOVATION CERAMIC ARTICULATION HIP SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE NITINOL STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

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