AUREX-3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADMS SILENT NEEDLE GUN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADMS MULTIPLANE RECTAL PROBE

FDA 510(k)

FDA Class 2 ·Radiology

KING OF HEARTS CDM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADMS TRANSRECTAL 7.5 MHZ PROBE

FDA 510(k)

FDA Class 2 ·Radiology

RESTORATION ADM SYSTEM X3 ACETABULAR

FDA 510(k)

FDA Class 2 ·Orthopedic

UNIVERSAL STAND FOR FILM CHANGER

FDA 510(k)

FDA Class 2 ·Radiology

PROBE SHEATH FOR ADMS ULTRASOUND PROBE

FDA 510(k)

FDA Class 2 ·Radiology

BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Athena GTX Device Management Suite (ADMS) Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMMULITE 2000 3RD GENERATION PSA

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 MIXED ALLERGEN PANELS

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 SPECIFIC ALLERGENS

FDA 510(k)

FDA Class 2 ·Immunology

CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 72-81-0 UNVENTED SOLUTION ADM. SET

FDA 510(k)

FDA Class 2 ·General Hospital