RIGI-FIX HIP STEM SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOSTEON CROSS PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

Irrigation Tubing with CO2 or Air

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIFOTI USB 2.0 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NDR+/DIVA-D

FDA 510(k)

FDA Class 2 ·Radiology

LITTLE GRAFTER SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM ON COBAS E 411

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassy Systems

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 601

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Acess AFP Reagents on the Access Immunoassay Systems