HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.

FDA 510(k)

FDA Class 2 ·Hematology

RESTOR (COMET)*DENTAL RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

COMPASS STEREOTACTIC POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BONDEX* GLASS IONOMER CEMENT

FDA 510(k)

FDA Class 2 ·Dental

FlexCath Advance Steerable Sheath and Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600

FDA 510(k)

FDA Class 2 ·Immunology

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology

IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROSA Spine

FDA 510(k)

FDA Class 2 ·Neurology

Epione

FDA 510(k)

FDA Class 2 ·Radiology

ROSA ONE Spine application

FDA 510(k)

FDA Class 2 ·Neurology

ROSA BRAIN (v3.0.0.5)

FDA 510(k)

FDA Class 2 ·Neurology

ROSA ONE Brain Application

FDA 510(k)

FDA Class 2 ·Neurology