Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

Gonococcal Antibody Tests

FDA Pre-Market Approval

FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo OP-05W(A)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo OP-05W (A)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo OP-05W(A)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05W (A)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo OP-05W(A)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO AP-05H ASAHI PLASMA SEPARATOR

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter