QUANTIMETRIC PLUS C3 REAGENT KIT

FDA 510(k)

FDA Class 2 ·Immunology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

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

VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VENUS SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FOCUS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LEXUS ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TorqVue Low Profile Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSLEEP

FDA 510(k)

FDA Class 2 ·Neurology

E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MiroCam Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIROCAM CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

E.G. SCAN II ESPHAGOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat