System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)

FDA 510(k)

FDA Class 2 ·Immunology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Immunology

Foot and Hand Motion

FDA 510(k)

FDA Class 2 ·Orthopedic

Xpert Wrist

FDA 510(k)

FDA Class 2 ·Orthopedic

Alians Clavicle range

FDA 510(k)

FDA Class 2 ·Orthopedic

Newclip Patient-matched instrumentation non sterile PSI

FDA 510(k)

FDA Class 2 ·Orthopedic

Footmotion Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

R&G Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEARTSTART 2000, MANUAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIR-CUSHION TOCOTONOMETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FETASCAN 1500

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FIRST MEDIC MODEL 610P

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

DIGI-PRO TENS MODEL WL-2203 AND WL-2205

FDA 510(k)

FDA Class 2 ·Neurology