GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARN CENTRIFUGAL PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDI BLOOD PARAMETER MONITORING SYSTEM 500

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDOS HILITE INFANT OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS VISIFLOW AORTIC ARCH CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS FILTERED CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES

FDA 510(k)

FDA Class 2 ·Cardiovascular

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Neurology

KINETDX

FDA 510(k)

FDA Class 2 ·Radiology

CDI BLOOD PARAMETER MONITORING SYSTEM 500

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS WARMER, PART #164975 AND #164980

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

BIOGLAS MICROCARRIER BEAD

FDA 510(k)

FDA Class 1 ·Hematology

AMYLASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SARNS 9000 HEART-LUNG CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AEROQUIP SAFESTART IV CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital