Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEMS

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EXCIMER LASER SYSTEM EC-5000

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·Nidek EC-5000 Excimer Laser System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ELASTIC LENS(TM) AA-4203 & CHIROFLEX(TM) 32-C10XX

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer Intraocular Lens

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·MENICON SF-P (MELAFOCON A) CONTACT LENS