ECHELON Synergy MRI System

FDA 510(k)

FDA Class 2 ·Radiology

Kitazato ET Catheters

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MOBILE X-RAY TELEVISION UNIT WHA-10A/B

FDA 510(k)

FDA Class 2 ·Radiology

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Dental

Nihon Kohden QP-160AK EEG Trend Program

FDA 510(k)

FDA Class 2 ·Neurology

PROBEAT-FR

FDA 510(k)

FDA Class 2 ·Radiology

Kitazato OPU Needles

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vantage Titan 1.5T, V3.1, MRT-1510

FDA 510(k)

FDA Class 2 ·Radiology

Canon OCT-A1

FDA 510(k)

FDA Class 2 ·Ophthalmic

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

FDA 510(k)

FDA Class 2 ·Dental

Real Time Image Gating System for Proton Beam Therapy Systems

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Orian 1.5T, MRT-1550, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Biliary Balloon Dilator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)

FDA 510(k)

FDA Class 2 ·Radiology

SUPER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIBER HEAD LIGHT FH-300

FDA 510(k)

FDA Class 2 ·Ophthalmic

PreXion3D Expedition

FDA 510(k)

FDA Class 2 ·Radiology

Diagnostic Imaging Color LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

OPM SLIT LAMP MODEL P-1 & MODEL P-3

FDA 510(k)

FDA Class 2 ·Ophthalmic