Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

Medi Derma-S Total Barrier Film Aerosol (BoV)

Device

EU MDR · Eu Md Class 1 ·Medicareplus International Limited·On the market

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr 5.5 EBV Circle Flange Valve

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 XPI ANTI-HBS

EBV/EA-CHECK TM TEST KIT

FDA 510(k)

FDA Class 1 ·Microbiology

BION EBV-G (VCA) TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

EBV-VCA-IGM IFA TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

EBV/VCA-CHECK(TM) ANTIGEN SLIDES

FDA 510(k)

FDA Class 1 ·Microbiology

EBV-CHECK(TM) TEST KIT (IGG)

FDA 510(k)

FDA Class 1 ·Microbiology

EBV-EA(D) IGG ELISA TEST

FDA 510(k)

FDA Class 1 ·Microbiology

EBV-VCA IGG ELISA TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

LIAISON EBV IgM Serum Control Set

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BIOTEST ANTI-EBV RECOMBINANT, EA IGM

FDA 510(k)

FDA Class 1 ·Microbiology

RESUBMITTED EBV/IGM-CHECK TEST KIT

FDA 510(k)

FDA Class 1 ·Microbiology

EBV VCA IGM ANTIBODY ASSAY KIT

FDA 510(k)

FDA Class 1 ·Microbiology

SERAQUEST EBV EA-D IGG TEST

FDA 510(k)

FDA Class 1 ·Microbiology

EBV-VCA IGM ELISA TEST STSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

BION EBV-M (VCA) TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

EBV(EPSTEIN-BARR VIRUS) TEST KIT

FDA 510(k)

FDA Class 1 ·Microbiology