ATLAS-BASED AUTOSEGMENTATION

FDA 510(k)

FDA Class 2 ·Radiology

NASAL/PARANASAL ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BREAST SIMULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PRECLUDE DURA SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Neurology

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

IV TRIFURCATED EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

HEMOLAB

FDA 510(k)

FDA Class 2 ·Hematology

GLYCATED PROTEIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EDTA GEL (TM)

FDA 510(k)

FDA Class 2 ·Dental

SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TERUMO ASPRIATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

FDA 510(k)

FDA Class 2 ·Orthopedic

ESCHMANN TDB50 BIPOLAR COAGULATION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITEK MS PRIME

FDA 510(k)

FDA Class 2 ·Microbiology