Pristine Scope

FDA 510(k)

FDA Class 2 ·Orthopedic

ProSeal™ Closed System drug Transfer Device (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

Pristine Arthroscopic Visualization System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pristine Scope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ONGUARD

Avicenna Roboflex

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE

GEMENI IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HAVAB-G

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON XL ANALYZER MODEL 10050

FDA 510(k)

FDA Class 2 ·Microbiology

ANTISERUM TO HUMAN IGM

FDA 510(k)

FDA Class 2 ·Immunology

MONOLISA ANTI-HAV EIA

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM

FDA 510(k)

FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO ACS CORONARY GUIDING

FDA 510(k)

FDA Class 2 ·Immunology

LIAISON Anti-HAV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

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

LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV

FDA 510(k)

FDA Class 2 ·Microbiology