81 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Australia
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ResMed PTY LTD
Manufacturer
🇦🇺 Australia·1 Basic UDI-DI·1 Device·2 Importers
Atomo Diagnostics Limited
Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
CareDx Pty Ltd
Manufacturer
🇦🇺 Australia
Ellex Medical Pty Ltd
Manufacturer
🇦🇺 Australia·17 Basic UDI-DIs·29 Devices·9 Importers·THERAPEUTIC GOODS ADMINISTRATION
Smartz Operations Pty Ltd
Manufacturer
🇦🇺 Australia
Livac Pty Ltd
Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·DQS Medizinprodukte GmbH
Proteomics International Pty Ltd
Manufacturer
🇦🇺 Australia
Plasma Shield Ltd
Manufacturer
🇦🇺 Australia
Intellirad Solutions Pty Ltd
Manufacturer
🇦🇺 Australia
Synx Sole Pty Ltd
Manufacturer
🇦🇺 Australia
Evertone Pty. Limited
Manufacturer
🇦🇺 Australia
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
FDA Enforcement
Class II
·Terminated·ResMed Ltd.·June 17, 2015
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
FDA Enforcement
Class I
·Completed·ResMed Ltd.·February 12, 2020
AirFit N10 Nasal Masks and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirTouch N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023
AirFit F30 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirTouch F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023