Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA FAMILY OF LEADS

AutonoME

FDA registration

ACCESSIBILITY SERVICES, INC.·1 product·🇺🇸 United States

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

International Medical Research Pty. Ltd.

Manufacturer

🇦🇺 Australia

Biosensors Interventional Technologies Pte Ltd

Manufacturer

🇸🇬 Singapore·1 Importer

Kleen-Pak Products Pte Ltd

Manufacturer

🇸🇬 Singapore

Contract Sterilization Services Pte Ltd

Manufacturer

🇸🇬 Singapore

Bio-Molecular Systems Pty Ltd

Manufacturer

🇦🇺 Australia·2 Importers

Digital Life Line Pte Ltd

Manufacturer

🇸🇬 Singapore·1 Basic UDI-DI·2 Devices

Vela Operations Singapore Pte. Ltd.

Manufacturer

🇸🇬 Singapore·75 Basic UDI-DIs·82 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Concourse Assistive Technology Pty Ltd

Manufacturer

🇦🇺 Australia·1 Basic UDI-DI·1 Device

HOYA Medical Singapore Pte. Ltd.

Manufacturer

🇸🇬 Singapore

United Pacific Industries Pty Ltd

Manufacturer

🇦🇺 Australia·3 Importers

Advanced Ophthalmic Innovations Pte. Ltd.

Manufacturer

🇸🇬 Singapore·1 Basic UDI-DI·1 Device·4 Importers·TÜV Rheinland LGA Products GmbH

Leica Biosystems Melbourne Pty Ltd

Manufacturer

🇦🇺 Australia

SYAI HEALTH TECHNOLOGY PTE. LTD.

Manufacturer

🇸🇬 Singapore·1 Basic UDI-DI·4 Devices·1 Importer

SMR Automotive Australia Pty Limited

Manufacturer

🇦🇺 Australia

Merit Medical Singapore Pte. Ltd.

Manufacturer

🇸🇬 Singapore·1 Importer

NDR MEDICAL TECHNOLOGY PTE. LTD.

Manufacturer

🇸🇬 Singapore