Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFIL N-BCA LIQUID EMBOLIC 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)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Tryton Side Branch Stent

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

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TC65B-SUV

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

FDA Pre-Market Approval

FDA Class 3 ·NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS)

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) BRAND CONTACT LENSES,VISTAKON(ETAFILCON A) BRAND CONTACT LENSES

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART CONTROL NITINOL STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES

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) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART NITINOL STENT SYSTEM/SMART CONTROL NITINOL STENT SYSTEMS

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7