Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Rotlex IOLA MFD

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Mynx Control Vascular Control Device, Mynx Control Venous Vascular Control Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·INFINITY LS EXCIMER LASER SYSTEM

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Relay Thoracic Stent-Graft with Plus Delivery System

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

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

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ BALLOON-EXPANDABLE STENT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

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 ·EXOSEAL VASCULAR CLOSURE DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER

Stent, Iliac

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS

Stent, Coronary

FDA Pre-Market Approval

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

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·STAT-PACE II ESOPHAGEAL PACING SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES MODELS PA38E-OUV AND PL52A-OUV