HYBRID SURGICAL DEVICES, MODIFICIATION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUALTHERM(R) CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML

FDA 510(k)

FDA Class 2 ·General Hospital

VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EUB-450 DIAGNOSTIC ULTRASOUND DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

SURGIFLATOR-30

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYN-Pump PH304

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IV FLUID TRANSFER PIN

FDA 510(k)

FDA Class 2 ·General Hospital

ENDOSCOPIC CAMERA TC804/C4

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Advocate Insulin Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

i-STAT CG4+ cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aquilex Fluid Control System AQL-100S

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL

FDA 510(k)

FDA Class 2 ·Radiology

DISPENSING PIN WITH ONE-WAY VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

EEG 130

FDA 510(k)

FDA Class 2 ·Neurology

IMLOGIX 1000 IMAGE DISPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TERUMO MICRO TAPERED PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

VIRECTOMY LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic