Y-MIC

FDA 510(k)

FDA Class 2 ·Dental

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Elan 1.5T, MRT-2020, V6.0

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning, TSX-035A/4 and /5, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOREF LENSMETER RL-10

FDA 510(k)

FDA Class 1 ·Ophthalmic

CSX-30 Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)

FDA 510(k)

FDA Class 2 ·Radiology

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

RX Takeru Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

4MP COLOR LCD MONITOR, RADIFORCERX430

FDA 510(k)

FDA Class 2 ·Radiology

Elefix V Paste for EEG & EMG

FDA 510(k)

FDA Class 2 ·Neurology

8MP Color LCD Monitor, RadiForce RX850, RX850-AR

FDA 510(k)

FDA Class 2 ·Radiology

Sperm Freeze, Sperm Fridge

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)

FDA 510(k)

FDA Class 2 ·Radiology

2MP COLOR LCD MONITOR, RADIFORCE MX215

FDA 510(k)

FDA Class 2 ·Radiology

XIDF-AWS801, Angio Workstation, V6.10

FDA 510(k)

FDA Class 2 ·Radiology

TOKUYAMA CUREGRACE

FDA 510(k)

FDA Class 2 ·Dental