Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

STERILE WATER & STERILE 0.9% SODIUM CHLORIDE

FDA 510(k)

FDA Class 2 ·General Hospital

THE DOCTOR'S CHOICE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

ENGPLUS

FDA 510(k)

FDA Class 2 ·Neurology

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

R&G Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

UMBILI-CATH-S

FDA 510(k)

FDA Class 2 ·General Hospital

BARD UMBILICAL VESSEL CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

CATHETER, UMBILICAR ARTERY

FDA 510(k)

FDA Class 2 ·General Hospital