Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·STRAUMANN EMDOGAIN

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON B SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION (VASURFILCON A) SOFT CONTACT LENSES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IOL Sterile UV-Absorbing Acrylic, Foldable Multipiece Posterior Chamber, Lenses, AcrySof™ Natural UV and Blue L

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION EXTENDED WEAR SOFT CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER IOL'S

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Single-Piece PMMA Posterior Chamber IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Single-Piece PMMA Anterior Chamber IOLs

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryGel Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryShape Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Ideal Implant Saline-filled Breast Implant

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor-Saline-Filled and Spectrum Breast Implants