APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

FDA 510(k)

FDA Class 2 ·Immunology

DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ZIRBLOCK

FDA 510(k)

FDA Class 2 ·Dental

InstaRISPACS / InstaZFP / InstaMobi v5.0

FDA 510(k)

FDA Class 2 ·Radiology

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

NUVOX BEDSIDE TINNITUS MASKER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX ST-1A

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

M/D4 W/CHARGER (CARDIOPAC 3M11)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SE-CHECK

FDA 510(k)

FDA Class 2 ·Hematology

PHYSIOLOGICAL MONITOR 2100

FDA 510(k)

FDA Class 2 ·Cardiovascular

NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING

FDA 510(k)

FDA Class 2 ·Dental

MYOTRAC/S, MYODAC/S

FDA 510(k)

FDA Class 2 ·Neurology

FILTERFLO H

FDA 510(k)

FDA Class 2 ·Anesthesiology

CD-CHEX CD4 LOW

FDA 510(k)

FDA Class 2 ·Hematology

BACTTRAP

FDA 510(k)

FDA Class 2 ·Anesthesiology

EDD

FDA 510(k)

FDA Class 2 ·Anesthesiology

WEINGART MODEL 1000 SUNLAMP PRODUCT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery