RVT CTO DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RA-308 Excimer Laser System, Excimer Laser Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO THE CROSSER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CROSSER CTO Recanalization Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OCELOT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PowerWire Radiofrequency Guidewire Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Artemis Hand Held Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Besmed Peak Flow Meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia

FDA classification

FDA Class 2 ·Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia

Endoscope Introducer Kit

FDA classification

FDA Class 2 ·Endoscope Introducer Kit

TRIBALL INCENTIVE SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DISPOSABLE PRESSURE MANOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Powersculp laser lipolysis system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery