HYPO-GARD

FDA 510(k)

FDA Class 2 ·General Hospital

EPI-SCAN, MODEL P 100

FDA 510(k)

FDA Class 2 ·Neurology

Minder System

FDA 510(k)

FDA Class 2 ·Neurology

API UNISCEPT (TM) KB

FDA 510(k)

FDA Class 2 ·Microbiology

API UNISCEPT MIC 100UL

FDA 510(k)

FDA Class 2 ·Microbiology

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS

MODIFICATION MIC/API UNISCEPT(R)

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATIONS TO API UNISCEPT (R) KB

FDA 510(k)

FDA Class 2 ·Microbiology

API UNISCEPT MIC/UNISCEPT MICRO-MIC

FDA 510(k)

FDA Class 2 ·Microbiology

API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC

FDA 510(k)

FDA Class 2 ·Microbiology

API UNISCEPT KB/TYPE 2 AND 3

FDA 510(k)

FDA Class 2 ·Microbiology

e-SDF

FDA 510(k)

FDA Class 2 ·Dental

PORT ACCESS NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

INTERMITTENT INJECTION SITE

FDA 510(k)

FDA Class 2 ·General Hospital

RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORT ACCESS INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE