AU5800(R) CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION

FDA 510(k)

FDA Class 2 ·Radiology

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

FDA 510(k)

FDA Class 2 ·Cardiovascular

MILLENNIUM MLC -120

FDA 510(k)

FDA Class 2 ·Radiology

COULTER GEN-S SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO GE LOGIQ A3

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 6416 TEMPORARY PACING LEAD SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES

FDA 510(k)

FDA Class 2 ·Hematology

SUPER SHEATH INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

LOGIQ S8

FDA 510(k)

FDA Class 2 ·Radiology

COULTER AC.T DIFF ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

MAGNETOM Vida

FDA 510(k)

FDA Class 2 ·Radiology

CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1

FDA 510(k)

FDA Class 2 ·Hematology

THE AMO OPHTHALMIC SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

MULTIX Impact C

FDA 510(k)

FDA Class 2 ·Radiology

Respiratory Panel

FDA classification

FDA Class 2 ·Respiratory Panel

N LATEX STFR REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

N PROTEIN STANDARD SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry