Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BLAIREX STERILE SALINE SOLUTION

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 ·NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Suture, Nonabsorbable

FDA Pre-Market Approval

FDA Class 2 ·MERSILENE*POLYESTER SUTURE

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.0

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SORBI-CARE(TM) DAILY LENS CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·C-65 DAILY CONTACT LENS CLEANER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED REBEL PTCA CATHETER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL)

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS