Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA Single-Piece Anterior Chamber Intraocular Lens

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT(TM)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

PROFEMUR XTR HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR TAPERED HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR(R) E CEMENTLESS HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

CONSERVE PLUS QUADRAFIX ACETABULAR SHELL

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR HIP SYSTEM MODULAR NECKS

FDA 510(k)

FDA Class 3 ·Orthopedic

ANTERIOR APPROACH HIP SURGERY INSTRUMENTS

FDA 510(k)

FDA Class 3 ·Orthopedic

LINEAGE HA ACETABULAR SHELLS

FDA 510(k)

FDA Class 3 ·Orthopedic

DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR RENAISSANCE HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

CONSERVE THIN SHELL

FDA 510(k)

FDA Class 3 ·Orthopedic