Lunoa System

FDA 510(k)

FDA Class 2 ·Dental

IMPULSE SEALER PRODUCT LINE

FDA 510(k)

FDA Class 2 ·Dental

PERMAGEN F/DC

FDA 510(k)

FDA Class 2 ·Dental

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System

FDA 510(k)

FDA Class 2 ·Dental

MEDISIZE GOLD HEATER AND BOOSTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

MULTIPLE-LENS, SPECTACLES, CUSTOM

FDA 510(k)

FDA Class 2 ·Ophthalmic

CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

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

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

DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM

FDA 510(k)

FDA Class 2 ·General Hospital

600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE

FDA 510(k)

FDA Class 2 ·Cardiovascular