Ultrasound System SONIMAGE MX1

FDA 510(k)

FDA Class 2 ·Radiology

WHILL Model C2

FDA 510(k)

FDA Class 2 ·Physical Medicine

SUPER URINE ANALYZER SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

FDA 510(k)

FDA Class 2 ·Cardiovascular

JMS DIALYZER PRIMING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Green Laser Photocoagulator GYC-500

FDA 510(k)

FDA Class 2 ·Ophthalmic

OC-Light S FIT

FDA 510(k)

FDA Class 2 ·Hematology

Neuromaster G1 MEE200

FDA 510(k)

FDA Class 2 ·Neurology

Synapse 3D Blood Flow Analysis

FDA 510(k)

FDA Class 2 ·Radiology

VMA EIA KIT YAMASA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Single Use Hot Biopsy Forceps FD-231

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Immucise Intradermal Injection System

FDA 510(k)

FDA Class 2 ·General Hospital

Aquilion ONE (TSX-306A/3) V10.0

FDA 510(k)

FDA Class 2 ·Radiology

MODEL SSD-710

FDA 510(k)

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DBB-06 HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOWA NONMYD 7, KOWA NONMYD A-D

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKR 3000

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology