PINPOINT Endoscopic Fluorescence Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OptiVu™ ROSA® MxR

FDA 510(k)

FDA Class 2 ·Neurology

Change Healthcare Stratus Imaging PACS

FDA 510(k)

FDA Class 2 ·Radiology

NHMC FOLEY CATHETERIZATION TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE DIVACUP MENSTRUAL SOLUTION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FLEXCOMP DSP & PROCOMP

FDA 510(k)

FDA Class 2 ·Neurology

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MINUTEX D-DIMER LATEX TEST

FDA 510(k)

FDA Class 2 ·Hematology

BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Comet-PLUS

FDA 510(k)

FDA Class 2 ·Neurology

ACU-RAY

FDA 510(k)

FDA Class 2 ·Radiology

SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GenePOC CDiff

FDA 510(k)

FDA Class 2 ·Microbiology

SONIXGPS VASCULAR ACCESS NEEDLE KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SINGLE CHANNEL BALLOON CANNULA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

XPLORER 1000

FDA 510(k)

FDA Class 2 ·Radiology

SKYLARK MODEL 1001 TENS DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

ExpanSure Transseptal Dilation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Darwin

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery