ALPHA II DIAGNOSTIC X-RAY

FDA 510(k)

FDA Class 2 ·Radiology

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

RESUBMITTAL OF MI 1000C MICROIMAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

StarPore

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LTU-904 PORTABLE LASER THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Rapid Surgical Plan (RSP-SW-001)

FDA 510(k)

FDA Class 2 ·Radiology

AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

DENE BRIDGE

FDA 510(k)

FDA Class 2 ·Dental

EPS320 CARDIAC STIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Precision Screw

FDA 510(k)

FDA Class 2 ·Neurology

MANIPULATOR; MANIPULATOR PRO

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

NEUROMONICS TINNITUS TREATMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

H59 CRITICAL CARE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

D668 & D664 CENTRAL MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUMAP AUTOMATIC PERIMETER

FDA 510(k)

FDA Class 2 ·Neurology

Nurochek System

FDA 510(k)

FDA Class 2 ·Neurology

InsufflatOR Needle

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MARK II/MARK III MANOMETRIC PERFUSION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology