CMV MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

APTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

COE PAK AUTO MIX, REGULAR OR HARD SET

FDA 510(k)

FDA Class 2 ·Dental

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

FDA 510(k)

FDA Class 2 ·Microbiology

PROTEIN S CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILK'N FX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POREX(TM) PROSTHESIS, CHIN, INTERNAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO: VELSCOPE

FDA 510(k)

FDA Class 2 ·Dental

ORTHO* RUBELLA-G ANTIBODY ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL FT-100 INTRACRANIAL PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

BT-1 INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

0.5T ASSET SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASA ORAL APPLIANCES

FDA 510(k)

FDA Class 2 ·Dental

NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STERIGAGE EO 100%

FDA 510(k)

FDA Class 2 ·General Hospital

OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat