HYALOMATRIX CO

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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 (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

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 ·MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·COOK MBC PTCA BALLOON DILATATION CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SCANLENS (SCAFILCON A CONTACT LENS)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS STEERABLE PTCA BALLOON CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·PREFLEX AND FLEXCARE SOL.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FEMIDOM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM ANTIBODY TO HCV

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

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)

Susceptibility Test Discs, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MS 2 AUTOMATED SYSTEM

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA