GEM-PREMIER SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DRUG RECONSTITUTION FILTER DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED SARNS MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESSURE TUBING AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SARNS INGANT MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

XORANCONNECT

FDA 510(k)

FDA Class 2 ·Radiology

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

NANOBEAM 940, MODEL 940-900-02

FDA 510(k)

FDA Class 2 ·Physical Medicine

VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SARNS 9000 UNIVERSAL ROLLER PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLYDE (TM) FILTRATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Aurora

FDA 510(k)

FDA Class 2 ·Dental

SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNGO DYNAMICS

FDA 510(k)

FDA Class 2 ·Radiology

QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CLEM TM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SARNS FILTERED VENOUS RESERVIOR MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular