USA Elite

FDA UDI

Gyrus Acmi, Inc.·00821925038479·ACMI USA Elite System and USA Series Right Angl...

USA Elite

FDA UDI

Gyrus Acmi, Inc.·00821925036437·ACMI USA Elite System and USA Series Right Angl...

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MARA Water Vapor Ablation System

VARELISA PARIETAL CELL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

CS.Neo2

FDA registration

CADSTAR TECHNOLOGY GMBH·1 product·🇦🇹 Austria

IO-a LED; IO-a LED CAMERA

FDA registration

NEITZ INSTRUMENTS COMPANY, LTD.·1 product·🇯🇵 Japan

MDE Kft.

Manufacturer

🇭🇺 Hungary·1 Basic UDI-DI·1 Device·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)

IO- LED, IO- LED CAMERA

FDA registration

NEITZ INSTRUMENTS COMPANY, LTD.·1 product·🇯🇵 Japan

MEL Medical GmbH

Manufacturer

🇩🇪 Germany

Agu-Punt SL

FDA registration

AGUPUNT S.L.·1 product·🇪🇸 Spain

IO-a; IO-a LED

FDA registration

NEITZ INSTRUMENTS COMPANY, LTD.·1 product·🇯🇵 Japan

FEMNA Health M.E. GmbH

Manufacturer

🇩🇪 Germany·1 Basic UDI-DI·1 Device

ECAM SCINTRON

FDA registration

MIE GMBH·1 product·🇩🇪 Germany

MIE - LFOV SCINTRON

FDA registration

MIE AMERICA, INC.·2 products·🇺🇸 United States