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

HammerTechTM Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

LAKE WOUND CARE/TREATMENT KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LAKE MALE EXTERNAL CATHETERIZATION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPERAID SURGICAL DRAIN

FDA 510(k)

FDA Class 2 ·Ophthalmic

RAPIDTEG TEG-ACT TEST

FDA 510(k)

FDA Class 2 ·Hematology

Imperative Care Radial 088 Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PolyLock Small Bone Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

STAGE ZERO AIR FLOTATION BED

FDA 510(k)

FDA Class 2 ·Physical Medicine