FACTOR IX DEFICIENT PLASMA, B9D -

FDA 510(k)

FDA Class 2 ·Hematology

FREEMIE BREAST COLLECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FREEMIE (R)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Freemie Independence, Freemie Liberty

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Visaris Avanse

FDA 510(k)

FDA Class 2 ·Radiology

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

FDA 510(k)

FDA Class 2 ·Radiology

Hi-Bond Universal

FDA 510(k)

FDA Class 2 ·Dental

IMPROVACUTER GEL & CLOT ACTIVATOR TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

X2ABS DUAL CHANNEL FITNESS BELT

FDA 510(k)

FDA Class 2 ·Physical Medicine

HYDROPREP GEL

FDA 510(k)

FDA Class 2 ·Neurology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·AMCON DUO

SURFAS

FDA 510(k)

FDA Class 2 ·Radiology

GEMENI IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANTISERUM TO HUMAN IGM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ACS CORONARY GUIDING

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology

ALKALINE PHOSPHATASE ISOYZME REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry