ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)

FDA 510(k)

FDA Class 2 ·Radiology

ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOCAL REPORT GENERATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTABLATOR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

DURALASTIC SHEETING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAINSTER WIDE FIELD LASER LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

FDA 510(k)

FDA Class 2 ·Cardiovascular

VBMAX

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCUCOM CARDIAC OUTPUT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIMAX MODEL FX-2111

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE PENILE BLOOD PRESSURE CUFFS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MED-4000

FDA 510(k)

FDA Class 2 ·Neurology

LIFEPAK 200

FDA 510(k)

FDA Class 2 ·Cardiovascular

SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

POLY STAT HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GARAVENTA SUPER-TRAC TRE-52

FDA 510(k)

FDA Class 2 ·Physical Medicine

FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERIZONE CHEMICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital