VENTANA CEA PRIMARY ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

Neurolutions Upper Extremity Rehabilitation System

FDA 510(k)

FDA Class 2 ·Neurology

ALERTWATCH: OR

FDA 510(k)

FDA Class 2 ·Cardiovascular

END 200 Endoscopic Tubeset

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOW PROFILE GASTROMSTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECG App

FDA 510(k)

FDA Class 2 ·Cardiovascular

Irregular Rhythm Notification Feature

FDA 510(k)

FDA Class 2 ·Cardiovascular

EndoFLIP® System with FLIP Topography module

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EsoFLIP® ES-310 Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Béa Applicator (BAP-GB-01)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CEA DESALTING DOLUMN SEPHADEX R

FDA 510(k)

FDA Class 2 ·Immunology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-RIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK CEA ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS CEA ON THE ELECSYS 1010

FDA 510(k)

FDA Class 2 ·Immunology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN TEST{R} CEA