SIGMA

FDA 510(k)

FDA Class 2 ·Dental

RP CUTTING NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OpenSight

FDA 510(k)

FDA Class 2 ·Radiology

Low Dose CT Lung Cancer Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETIC RESONANCE DIAGNOSTIC DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ElucidVivo A.3

FDA 510(k)

FDA Class 2 ·Radiology

SIGN IM NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

VERSAPULSE MODEL P20 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECHELON SHOULDER COIL

FDA 510(k)

FDA Class 2 ·Radiology

Savvy Surgical Mask - Level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TUBETECH IV Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

AXSYM BARBITURATES II U

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TDX SP2 POWER WHEECHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Supria Whole-body X-ray CT System

FDA 510(k)

FDA Class 2 ·Radiology

AXSYM COCAINE METABOLITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SUPRIA w/guideShot Option

FDA 510(k)

FDA Class 2 ·Radiology

ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology