AHI System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAINLINE MAXIE HCG URINE PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT

FDA 510(k)

FDA Class 1 ·Anesthesiology

SARNS SOFT-FLOW EXTENDED AORTIC CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS TEMPERATURE PROBE AND CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FST CATH-UD CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FST CATH UD-DUAL DUAL PRESSURE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)

FDA 510(k)

FDA Class 2 ·Cardiovascular

M-LINK

FDA 510(k)

FDA Class 2 ·Radiology

SARNS SAFETY LOOP

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRON

FDA 510(k)

FDA Class 2 ·Radiology

SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.

FDA 510(k)

FDA Class 2 ·Anesthesiology

DELPHIN II CENTRIFUGAL SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DELTAMANAGER

FDA 510(k)

FDA Class 2 ·Radiology

SARNS EVACUPLEGE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB

FDA 510(k)

FDA Class 1 ·Microbiology

MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)

FDA 510(k)

FDA Class 2 ·Cardiovascular