OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RadiForce RX570; RadiForce RX570-AR

FDA 510(k)

FDA Class 2 ·Radiology

Radifocus Optitorque Angiographic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

High Flow Insufflation Unit (UHI-4)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KATANA Cleaner, KATANA Cleaner (Trial)

FDA 510(k)

FDA Class 2 ·Dental

Asahi ViE-U Series Dialyzer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THERMOPLATE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

True Enhance DL

FDA 510(k)

FDA Class 2 ·Radiology

YELLOW LASER PHOTOCOAGULATOR YLC-500

FDA 510(k)

FDA Class 2 ·Ophthalmic

5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510

FDA 510(k)

FDA Class 2 ·Radiology

Vitrea Software Package, VSTP-001A

FDA 510(k)

FDA Class 2 ·Radiology

COLOR LCD MONITOR, RADIFORCE, MODEL RX210

FDA 510(k)

FDA Class 2 ·Radiology

21.3 INCH MONOCHROME LCD MONITOR

FDA 510(k)

FDA Class 2 ·Radiology

COMPORUS

FDA 510(k)

FDA Class 2 ·Orthopedic

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES

FDA 510(k)

FDA Class 2 ·Radiology

SB Soft Hood - Straight type, SB Soft Hood - Undercut type

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

PreXion 3D Excelsior

FDA 510(k)

FDA Class 2 ·Radiology

VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2

FDA 510(k)

FDA Class 2 ·Dental