IMAGEnet6 Ophthalmic Data System

FDA 510(k)

FDA Class 2 ·Radiology

Cufitec Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASAHI PTCA Guide Wire ASAHI SUOH 03

FDA 510(k)

FDA Class 2 ·Cardiovascular

Konicaminolta DI-X1

FDA 510(k)

FDA Class 2 ·Radiology

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

FDA 510(k)

FDA Class 2 ·Dental

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Infinix-i, INFX-8000V, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

Esthetic Colorant

FDA 510(k)

FDA Class 2 ·Dental

UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle

FDA 510(k)

FDA Class 2 ·Anesthesiology

OC-Auto SENSOR io iFOB Test

FDA 510(k)

FDA Class 2 ·Hematology

BIOSUC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RETINA CAMERA TRC-NW7SF MARK II

FDA 510(k)

FDA Class 2 ·Ophthalmic

K-Shield Advantage Port Access Infusion Set (PAIS)

FDA 510(k)

FDA Class 2 ·General Hospital

IM-5B MICROINJECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Mochida Nerve Cuff

FDA 510(k)

FDA Class 2 ·Neurology

Kitazato IUI Catheter

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ReBOSSIS85

FDA 510(k)

FDA Class 2 ·Orthopedic

TG-970P CO2 Sensor Kit

FDA 510(k)

FDA Class 2 ·Anesthesiology