TEARAWAY INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION

FDA 510(k)

FDA Class 2 ·Hematology

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

NASALGUARD

FDA 510(k)

FDA Class 2 ·General Hospital

MIND MAP (20 CHANNEL EEG)

FDA 510(k)

FDA Class 2 ·Neurology

HYUNJAE DENTAL IMPRESSION MATERIALS

FDA 510(k)

FDA Class 2 ·Dental

DYNAMIC GAS SCAVENGING SYSTEM (DGSS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ClearGuard HD Antimicrobial Barrier Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLEARGUARD HD END CAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENUS BASIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

STATUSFLOW

FDA 510(k)

FDA Class 2 ·Hematology

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION

FDA 510(k)

FDA Class 2 ·Hematology

CD-CAL PLUS CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology