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

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

NEUROTECH RECOVERY

FDA 510(k)

FDA Class 2 ·Neurology

ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS

FDA 510(k)

FDA Class 2 ·General Hospital

HammerTechTM Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

SONICAID SYSTEM 8002

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SILIMED CHIN IMPLANTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery