Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER MYSTIC(TM) 20,30,40 MC PTCA CATHETERS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BAUSCH & LOMB STERILE PRESERVED SALINE SOLN

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·THERASONIC LITHOTRIPSY TREATMENT SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BONNIE (TM) PTCA CATHERS

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·MODEL NO. ALS-IV HEAT DISINFECTION UNIT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·AMERICAN EDWARDS LABS HYBRID PTCA CATHETER

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·PALACOS R BONE CEMENT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE WEEKLY CLEANING SOLUTION

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS

Accessories, Soft Lens Products

FDA Pre-Market Approval

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·B&L SENSITIVE EYES(TM) SALINE/CLEANING SOLUTION

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

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

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(TM) CONTACT LENS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTLENS CLEANING AND SOAKING SOL.

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·ETHIBOND*