SATURATION/HEMATOCRIT MONITOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT* PREBYPASS FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOSED CHEST SUPPORT CIRCUIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MVR COLLAPSIBLE VENOUS RESERVOIR BAG

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXIMA FORTE HARDSHELL VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXIMA PLUS HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT FILTERED CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCR4000 & MCR4000F CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NilRead

FDA 510(k)

FDA Class 2 ·Radiology