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

COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA TEST KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA DIAGNOSTIC KIT

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA LABELING CHANGE

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-EIA DIAGNOSTIC TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

SMPLE PLATE AND SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

twiist system

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET FORERUNNER LOCKING PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAC MALE ADAPTER

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET GRAFT DELIVERY SYRINGES

FDA 510(k)

FDA Class 2 ·General Hospital