AUTO SECTOR MCU

FDA 510(k)

FDA Class 2 ·Radiology

ICE COMPRESSION FIRST, DUO, & MOOVE Systems

FDA 510(k)

FDA Class 2 ·Physical Medicine

Powered wheelchair (mobility robot) (M4, M4U)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sleepware G3

FDA 510(k)

FDA Class 2 ·Neurology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGOIRITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Wireless EEG System

FDA 510(k)

FDA Class 2 ·Neurology

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ATOZ Mini-Screw

FDA 510(k)

FDA Class 2 ·Dental

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES WHOLE BLOOD ASSAY

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD