Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

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 ·MYNX ACE VASCULAR CLOSURE DEVICE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SMART CONTROL NITINOL STENT SYSTEMS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART AND SMART CONTROL NITINOL STENT SYSTEM

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS,

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RelayPro Thoracic Stent-Graft System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY BALLOON EXPANDABLE STENT WITH RAPTOR OTW DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTOR OTW

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM

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 ·ACUVUE CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS