ONE TRAY® Sealed Sterilization Container System

FDA 510(k)

FDA Class 2 ·General Hospital

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ-TRAXTM Persona Knee Containment Device

FDA 510(k)

FDA Class 2 ·General Hospital

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

FDA 510(k)

FDA Class 2 ·General Hospital

AI Platform 2.0 (AIP002)

FDA 510(k)

FDA Class 2 ·Radiology

Strain AI (SAI001)

FDA 510(k)

FDA Class 2 ·Radiology

CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOCLAV VENOUS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladder AI (AIBV01)

FDA 510(k)

FDA Class 2 ·Radiology

AI Platform (AIP001)

FDA 510(k)

FDA Class 2 ·Radiology

Lung AI (LAI001)

FDA 510(k)

FDA Class 2 ·Radiology

OXITRON OXYGEN SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

OXITRON OXYGEN ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Surgifoam Absorbable Gelatin Sponge, U.S.P.

FUKUDA DENSHI

FDA UDI

FUKUDA DENSHI CO.,LTD.·04538612909962·

FUKUDA DENSHI

FDA UDI

FUKUDA DENSHI CO.,LTD.·04538612910807·

FUKUDA DENSHI

FDA UDI

FUKUDA DENSHI CO.,LTD.·04538612230103·

FUKUDA DENSHI

FDA UDI

FUKUDA DENSHI CO.,LTD.·04538612911842·

FUKUDA DENSHI

FDA UDI

FUKUDA DENSHI CO.,LTD.·04538612230127·