Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COSTASIS/DYNASTAT SURGICAL HEMOSTATS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip Vascular Closure Device and two components of Mynx Control Vascular Closure Device (VCD)

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SBL-3 Multifocal Intraocular Lens

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cordis® Exoseal® Vascular Closure Device

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·INTRAOCULAR LENSES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODELS PA15,30,35,36,48,58

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Mynx Control Vascular Closure Device

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT WITH OTW DELIVERY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·THIXO

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Cordis S.M.A.R.T. CONTROL Nitinol Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)