3D Intraoral Scanner

FDA registration

GNI Co., LTD·1 product·🇰🇷 South Korea

GNI Ortho

FDA registration

GNI Co., LTD·1 product·🇰🇷 South Korea

GNI Ortho

FDA registration

GNI Co., LTD·1 product·🇰🇷 South Korea

GNI Ortho

FDA registration

GNI Co., LTD·1 product·🇰🇷 South Korea

BGI PathoGenesis Pharmaceutical Technology Co., Ltd.

Manufacturer

🇨🇳 China

Wuhan BGI Biomedical Engineering Co., Ltd.

Manufacturer

🇨🇳 China·3 Basic UDI-DIs·3 Devices

Beijing BGI-GBI Biotech Co., Ltd.

Manufacturer

🇨🇳 China

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 and NG4 Implantable Cardioverter Defibrillators (ICDs)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs

OC-Auto Sensor io iFOB Test

FDA registration

EIKEN CHEMICAL CO., LTD. NOGI PLANT·1 product·🇯🇵 Japan

OC-Light S FIT

FDA registration

EIKEN CHEMICAL CO., LTD. NOGI PLANT·1 product·🇯🇵 Japan

OC-Sensor DIANA iFOB Test

FDA registration

EIKEN CHEMICAL CO., LTD. NOGI PLANT·1 product·🇯🇵 Japan

OC-Auto Micro 80 FOB Test

FDA registration

EIKEN CHEMICAL CO., LTD. NOGI PLANT·1 product·🇯🇵 Japan

Northern Digital Inc.

Manufacturer

🇨🇦 Canada·17 Basic UDI-DIs·17 Devices·2 Importers·BSI Group The Netherlands B.V.

SillHa paper Test Strip Kit

FDA registration

ARKRAY, INC.·1 product·🇯🇵 Japan

ReliOn micro Blood Glucose Monitoring System

FDA registration

ARKRAY, INC.·1 product·🇯🇵 Japan

ReliOn Premier Lancing Device

FDA registration

ARKRAY, INC.·1 product·🇯🇵 Japan

GLUCOCARD 01

FDA registration

ARKRAY, INC.·3 products·🇯🇵 Japan

AUTION MAX AX-4060 Urinalysis System

FDA registration

ARKRAY, INC.·11 products·🇯🇵 Japan

AUTION MAX AX-4030

FDA registration

ARKRAY, INC.·11 products·🇯🇵 Japan