Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PERMATINT(R)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN TEST{R} CEA

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) DW (HEFILICON A) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ADD RGP LENS FINISHING LABORATORIES.

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·MIRASOL(TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLIDER(TM)/2.0 MM BALLOON DILATION CATHETER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TECHNOMED INTERNATIONAL SONOLITH 3000

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MIC TEST SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MIGHTY(TM) PTCA BALLOON DILITATION CATHETER

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HEATCASE(TM)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MIC TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E170

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·MIRASOL(TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SYNERGY(TM)CONV. RAPID EXCHANGE PTCA CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PERMATINT(R)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER