Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT ENDOPROSTHESIS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF(R) IQ TORIC INTRAOCULAR LENS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric Multifocal and Biofinity XR Toric (comfilconA)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA MULTI-PIECE POSTERIOR CHAMBER IOLS

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MARGINPROBE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE POSTERIOR CHAMBER IOLS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SILICOM(TM) 1000 RETINALTAMPONADE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK CORONARY STENT SYSTEMS