FDA Pre-Market Approval

ETI-AB-EBK PLUS Assay

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-EBK PLUS KIT

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DiaSorin ETI-EBK PLUS assay

Disposable Balloons

FDA registration

Given Imaging Vietnam Co., Ltd.·1 product·🇻🇳 Vietnam

Digitrapper pH Z

FDA registration

Given Imaging Vietnam Co., Ltd.·1 product·🇻🇳 Vietnam

Oximax Pulse Oximetry System

FDA registration

Given Imaging Vietnam Co., Ltd.·2 products·🇻🇳 Vietnam

EBI OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBM iDO Viewer 1.2.1

FDA 510(k)

FDA Class 2 ·Radiology

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

UDE

FDA 510(k)

FDA Class 2 ·Radiology

UniWeb 8.0

FDA 510(k)

FDA Class 2 ·Radiology

OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ICE Prettau

FDA registration

ZIRKONZAHN SRL·1 product·🇮🇹 Italy

ICE Transluzent Plus

FDA registration

ZIRKONZAHN SRL·1 product·🇮🇹 Italy

ZIRKONZAHN SRL

FDA registration

ZIRKONZAHN SRL·2 products·🇮🇹 Italy

ZIRKONZAHN SRL

FDA registration

ZIRKONZAHN SRL·1 product·🇮🇹 Italy

ZIRKONZAHN SRL

FDA registration

ZIRKONZAHN SRL·2 products·🇮🇹 Italy

ZIRKONZAHN SRL

FDA registration

ZIRKONZAHN SRL·1 product·🇮🇹 Italy

PROMIS

FDA registration

PROMIS SRL·1 product·🇮🇹 Italy