SYSTEM 50

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEDSYNAPSE Zero Footprint Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Medsynapse Ris Pacs & Medsynapse VNA

FDA 510(k)

FDA Class 2 ·Radiology

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VPOD ITPR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ADVANCED TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

NextDent Denture, E-Denture

FDA 510(k)

FDA Class 2 ·Dental

Sentimag System, Sentimark Magnetic Marker Systerm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD SPECTRIS MR INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD QWIK-FIX MRI DISPOSABLE KIT

FDA 510(k)

FDA Class 2 ·Radiology

BD Intraosseous Infusion System

FDA 510(k)

FDA Class 2 ·General Hospital

CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLOWGUARD CATHETERS & CANNALAE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOPUMP TUBING SET

FDA 510(k)

FDA Class 2 ·Cardiovascular