Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Anzai Respiratory Gating System

FDA 510(k)

FDA Class 2 ·Radiology

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAURIER SAFETY LONG SANITARY NAPKIN (MODIFICATION)

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

K-SHIELD Zen

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)

FDA 510(k)

FDA Class 2 ·Radiology

SURGIC IV IMPLANT CONTROL UNIT

FDA 510(k)

FDA Class 1 ·Dental

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