Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·DYNASOL 4

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·LITHOSTAR

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT KERATOCONUS METHAFILCON B

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX ALPHA(TM) .014 CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS CORONARY DILATATION CATHETERS (INDICATION)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ULTRA CARE (TM) NEUTRALIZING TABLET

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BRITE STOCK RE-WETTING/COMFORT DROPS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ONE(R) MULTI-PURPOSE SOLUTION

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON A) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) STACK 40(TM) CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·HYDROZYME WEEKLY ENZYMATIC CLEANER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER, MODEL HM3