EWC: ECG CABLE AND LEADWIRE SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

EWC: ECG II CABLE LEADWIRE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.

FDA 510(k)

FDA Class 2 ·Cardiovascular

TMS 1000 TEMP. MONITOR & PROBES

FDA 510(k)

FDA Class 2 ·General Hospital

D300 DOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

CPS-1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHODONITC METAL REINFORCED PLASTIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

ORTHODONTIC FACE BOW W/ INNER WIRE

FDA 510(k)

FDA Class 2 ·Dental

SMARTBOND

FDA 510(k)

FDA Class 2 ·Dental

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)

FDA Class 2 ·Immunology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Vista MMB Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology