FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MACH-SIGMA HANDPIECE, ULTRAPUSH

FDA 510(k)

FDA Class 1 ·Dental

FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008

FDA 510(k)

FDA Class 2 ·Cardiovascular

NON-MYDRIATIC RETINAL CAMERA, CR-45UAF

FDA 510(k)

FDA Class 2 ·Ophthalmic

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Titan 3T, MRT-3010/A7, M-Power GX

FDA 510(k)

FDA Class 2 ·Radiology

SIGNA Pioneer

FDA 510(k)

FDA Class 2 ·Radiology

Nihon Kohden Vital Sign Telemeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERABIEN MiLai

FDA 510(k)

FDA Class 2 ·Dental

Medi Lift PLUS

FDA 510(k)

FDA Class 2 ·Neurology

NIRO-200NX DP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Olympus Small Intestinal Capsule Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Alphenix, INFX-8000V/B, /S, V9.1

FDA 510(k)

FDA Class 2 ·Radiology

ENDOSCOPE REPROCESSOR OER-Elite

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JMS DIALYZER PRIMING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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