ECHOSTAR COMFORT 1.5T MRI

FDA 510(k)

FDA Class 2 ·Radiology

MID STREAM PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ECHOSTAR SPICA 1.5T MR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PYTON

FDA 510(k)

FDA Class 2 ·Anesthesiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

ALLURACLARITY XPER FD SERIES X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MEROCEL(R) LASER-GUARD(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ALLURA XPER FD; OR TABLE

FDA 510(k)

FDA Class 2 ·Radiology

POWERTREK INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOSAMA Reusable Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HOFFMAN IVF-1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRANSPORTABLE MODEL STS-T LITHOTRIPTER

TrainFES Advance

FDA 510(k)

FDA Class 2 ·Physical Medicine

PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015

FDA 510(k)

FDA Class 2 ·Dental

BOOM ARM

FDA 510(k)

FDA Class 2 ·Anesthesiology