Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSOAK

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(TM)

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·SHARPX NEEDLE DESTRUCTION UNIT

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC PANELS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTSITE (HEFILCON A) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE COMFORT DROPS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·DIASONICS NMR IMAGING SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·POLYMACON CONTACT LENSES

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE TETRACYCLINE

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HYBRID (PTCA) CATHETER