Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT,

Aeon Biotherapeutics Corp.

Manufacturer

🇹🇼 Taiwan·6 Basic UDI-DIs·6 Devices·BSI Group The Netherlands B.V.

Blink Device Company

Manufacturer

🇺🇸 United States·7 Basic UDI-DIs·14 Devices·1 Importer·BSI Group The Netherlands B.V.

IBL International GmbH

Manufacturer

🇩🇪 Germany·23 Basic UDI-DIs·29 Devices·BSI Group The Netherlands B.V.

USGI Medical

Manufacturer

🇺🇸 United States·6 Basic UDI-DIs·6 Devices·BSI Group The Netherlands B.V.

RECIPE Chemicals + Instruments GmbH

Manufacturer

🇩🇪 Germany·74 Basic UDI-DIs·97 Devices·BSI Group The Netherlands B.V.

Inovytec Medical Solutions Ltd.

Manufacturer

🇮🇱 Israel·25 Basic UDI-DIs·25 Devices·BSI Group The Netherlands B.V.

SYSTHEX - SISTEMAS DE IMPLANTES OSSEO INTEGRADO LTDA

Manufacturer

🇧🇷 Brazil·313 Basic UDI-DIs·313 Devices·BSI Group The Netherlands B.V.

Turner Imaging Systems, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

ENDRA Life Sciences, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

Diagnotix B.V.

Manufacturer

🇳🇱 Netherlands·29 Basic UDI-DIs·29 Devices·BSI Group The Netherlands B.V.

Rad Source Technologies Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

Micropace Pty Ltd

Manufacturer

🇦🇺 Australia·1 Basic UDI-DI·1 Device·3 Importers·BSI Group The Netherlands B.V.

Research and Production Company «Monitor» Limited

Manufacturer

🇷🇺 Russian Federation·9 Basic UDI-DIs·9 Devices·BSI Group The Netherlands B.V.

TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION

Manufacturer

🇮🇳 India·20 Basic UDI-DIs·20 Devices·1 Importer·BSI Group The Netherlands B.V.

Accuray Incorporated

Manufacturer

🇺🇸 United States·3 Basic UDI-DIs·3 Devices·1 Importer·BSI Group The Netherlands B.V.

Tristel Solutions Limited

Manufacturer

34 Basic UDI-DIs·35 Devices·6 Importers·BSI Group The Netherlands B.V.

Philips Medical Systems (Cleveland), Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

Qynapse

Manufacturer

🇫🇷 France·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

Inmet Garnick SA

Manufacturer

🇪🇸 Spain·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.