Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA HAFP TEST KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA XPRESS HAFP TEST SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA HAFP KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD,BLAZER II,BLAZER II HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER,BLAZER II HTD, AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II/PRIME HTD CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 13060 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 24070 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·THREE & SINGLE PIECE BIOCONVEX INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED LABELING FOR IOL 60 MOS.STERILITY EXPIR.