REFLEX EGR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DNA/RNA Shield SafeCollect Saliva Collection kit

FDA 510(k)

FDA Class 2 ·Microbiology

DNA/RNA Shield Collection Tube

FDA 510(k)

FDA Class 2 ·Microbiology

MIVI Mi-AXUS Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

VersaD Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite™ X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002

FDA 510(k)

FDA Class 2 ·Orthopedic

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETER

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

Suction Irrigation Tubing Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladeless Trocar; Bladed Trocar; Hasson Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TROCAR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUCTION/IRRIGATION KITTNER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLLY'S VITREOUS SCISSORS J-225-S

FDA 510(k)

FDA Class 2 ·Ophthalmic