Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE PATIENT DISINFECTION UNIT

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND TOPICAL SKIN ADHESIVE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MIC TEST SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MIC TEST SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·DURASOFT CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HEART TRAK PTCA CATHETER

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·ACCESS MOBILITY SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MIC TEST SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MICROSS-SL(TM) PTCA DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLIDER(TM) 018 CORONARY BALLOON SLEEVE MODIFI.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·DURASOFT CONTACT LENS