HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

FDA 510(k)

FDA Class 2 ·Immunology

TECHNICON H*1 SYSTEM (HDW)

FDA 510(k)

FDA Class 2 ·Hematology

HE4 EIA, MODEL: 404-10 US

FDA 510(k)

FDA Class 2 ·Immunology

ROMA (HE4 EIA + ARCHITECT CA 125 II)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPINEANALYER MODEL SAPOC

FDA 510(k)

FDA Class 2 ·Radiology

AN-10S ANDERSEN TUBE WITH STYLET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AN3200 DOUBILET DRAIN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ICON (TM) MODULAR PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)

FDA 510(k)

FDA Class 2 ·Orthopedic

FORZA SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Vision

FDA 510(k)

FDA Class 2 ·Dental

Sunny Cup and Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AIM (N/A)

FDA 510(k)

FDA Class 2 ·Anesthesiology