BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS CORTISOL REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CAPSET CALCIUM SULFATE BONE GRAFT PLASTER

FDA 510(k)

FDA Class 2 ·Dental

BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vitrea Advanced Visualization, Version 7.6

FDA 510(k)

FDA Class 2 ·Radiology

VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VITEK 2 GRAM POSITIVE MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

TENZCARE(TM) SNAP ELECTRODE 6867

FDA 510(k)

FDA Class 2 ·Neurology

TROCAR GRASPER/ANVIL APPROXIMATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DVX SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUCOSE(TRINDER) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100

FDA 510(k)

FDA Class 2 ·Cardiovascular

QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK

FDA 510(k)

FDA Class 2 ·Immunology

CAAS MRV VERSION 3.0

FDA 510(k)

FDA Class 2 ·Radiology

RRT TOTAL IGE TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology