Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS/EQUALENS II

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN TM PERFLUOROPROPANE (C3F8)GAS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING ELASTIMIDE(TM) MODELS AQ-1016VL, AQ-2003VL, AQ-2010VL POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ELASTIMIDE(TM) IOL MODEL AQ-2010

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA Pre-Market Approval

FDA Class 3 ·Et Control

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM