DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOFFMAN IVF-1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ProSeal™ Closed System drug Transfer Device (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRANSPORTABLE MODEL STS-T LITHOTRIPTER

NAMTAI ELECTRONIC BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

TMS-Cobot TS MV

FDA 510(k)

FDA Class 2 ·Neurology

TrainFES Advance

FDA 510(k)

FDA Class 2 ·Physical Medicine

VAPOFIL

FDA 510(k)

FDA Class 2 ·Anesthesiology

VAPORIZER SPACER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Sirius Max Dental Diode Curing Light

FDA 510(k)

FDA Class 2 ·Dental

VAPOFIL

FDA 510(k)

FDA Class 2 ·Anesthesiology

CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),

FDA 510(k)

FDA Class 2 ·Anesthesiology