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

MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310

FDA 510(k)

FDA Class 2 ·Radiology

Medical HAL Lower Limb Type (HAL-ML)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Vassallo GT 018 Hybrid

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISCOVERY MR750W 3.0T

FDA 510(k)

FDA Class 2 ·Radiology

AeroDR SYSTEM 2

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology