COAGUCHEK SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

BETA-CAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COAGUCHEK XS SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

PLASTINEX

FDA 510(k)

FDA Class 2 ·Hematology

Xprecia Stride Coagulation System, Xprecia System PT Controls

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS CS D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

DADE THROMBIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

FDA 510(k)

FDA Class 2 ·Immunology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

DIMENSION VISTA FLEX REAGENT CARTRIDGES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC

FDA 510(k)

FDA Class 2 ·Radiology

UNILYTE A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ti3Z Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Z-LINK CERVICAL

FDA 510(k)

FDA Class 2 ·Orthopedic

Zavation IBF

FDA 510(k)

FDA Class 2 ·Orthopedic

PROMEDICAL SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEROMAT MRS-1000

FDA 510(k)

FDA Class 2 ·Physical Medicine