TIMX LOW BACK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VSP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNI OXYGEN SYSTEM, MODEL 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

INSUFFLATOR TUBING KIT W/FILTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

FDA 510(k)

FDA Class 2 ·Cardiovascular

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892

FDA 510(k)

FDA Class 2 ·Neurology

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

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

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

FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UNIVERSAL STAND FOR FILM CHANGER

FDA 510(k)

FDA Class 2 ·Radiology

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