TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK 2 AST ST MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

GLUCOSE(TRINDER) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

FDA 510(k)

FDA Class 2 ·Dental

VIDAS TBI (GFAP, UCH-L1)

FDA 510(k)

FDA Class 2 ·Immunology

PEZO INTERBODY CAGES SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CERNER FETALINK (VERSION 1.0)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STERILE/SINGLE USE SYMBLEPHARON RING

FDA 510(k)

FDA Class 2 ·Ophthalmic

ATLAS-BASED AUTOSEGMENTATION

FDA 510(k)

FDA Class 2 ·Radiology

NASAL/PARANASAL ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

HEMOLAB

FDA 510(k)

FDA Class 2 ·Hematology

GLYCATED PROTEIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIPOLAR FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

VITEK 2 GRAM NEGATIVE LEVOFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B

FDA 510(k)

FDA Class 2 ·Anesthesiology

CHOLESTEROL CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ESCHMANN TDB50 BIPOLAR COAGULATION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery