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Sign in to claim this brandResmed Corp
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 9001 Spectrum Center Boulevard, San Diego, CA, 92123
- Website
- resmed.com
- —
- —
- [email protected]
- Phone
- 800-424-0737
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000115734
- DUNS Number
- 080243150
Catalogue (404)
Page 8 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Galapogos | K200565 | FDA 510(k) | Class II | Active |
| Airsoft F15 | K132901 | FDA 510(k) | Class II | Active |
| Resscan | K113815 | FDA 510(k) | Class II | Active |
| Airfit N10 | K132887 | FDA 510(k) | Class II | Active |
| Mirage Swift | K042403 | FDA 510(k) | Class II | Active |
| Swift Fx Nano | K123789 | FDA 510(k) | Class II | Active |
| Tasman | K112393 | FDA 510(k) | Class II | Active |
| Vpap Tx | K112914 | FDA 510(k) | Class II | Active |
| Resmed Hospital Full Face Mask | K041362 | FDA 510(k) | Class II | Active |
| Personalized Therapy Comfort Settings (PTCS) | K251657 | FDA 510(k) | Class II | Active |
| Vpap Iii | K030843 | FDA 510(k) | Class II | Active |
| AirFit N20 | K153673 | FDA 510(k) | Class II | Active |
| Scone Mask | K180497 | FDA 510(k) | Class II | Active |
| AirFit N20 | K161978 | FDA 510(k) | Class II | Active |
| Nasal Jacks Mask | K032433 | FDA 510(k) | Class II | Active |
| Menai System | K160836 | FDA 510(k) | Class II | Active |
| Mirage Full Face Mask Series 2 | K023244 | FDA 510(k) | Class II | Active |
| Swift Lt | K073638 | FDA 510(k) | Class II | Active |
| Astral 100/150 | K172875 | FDA 510(k) | Class II | Active |
| Mirage Micro | K072940 | FDA 510(k) | Class II | Active |
| Mirage Full Face Mask Series 2 | K023306 | FDA 510(k) | Class II | Active |
| Resmed Hospital Nasal Mask | K040566 | FDA 510(k) | Class II | Active |
| S9 Vpap Adapt With H5i | K102586 | FDA 510(k) | Class II | Active |
| S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV | K160822 | FDA 510(k) | Class II | Active |
| Sullivan Humidaire Heated Humidifier | K971260 | FDA 510(k) | Class II | Active |
| Restraxx Data Centre, Model R10 | K070746 | FDA 510(k) | Class II | Active |
| Easycare Online | K132371 | FDA 510(k) | Class II | Active |
| Juno VPAP ST-A | K161492 | FDA 510(k) | Class II | Active |
| Astral Ventilator | K133868 | FDA 510(k) | Class II | Active |
| Mirage Micro | K110444 | FDA 510(k) | Class II | Active |
| Darlinghurst Vented, Darlinghurst NV-AAV | K143603 | FDA 510(k) | Class II | Active |
| S9 Vpap St With H5i | K102513 | FDA 510(k) | Class II | Active |
| Vpap Iii St-A/Kidsta Mask System | K060105 | FDA 510(k) | Class II | Active |
| Mirage Liberty Full Face Mask | K063011 | FDA 510(k) | Class II | Active |
| myAir | K251889 | FDA 510(k) | Class II | Active |
| Mirage Echo | K090490 | FDA 510(k) | Class II | Active |
| Modification To Mirage Micro | K081321 | FDA 510(k) | Class II | Active |
| Vpap Iii St-A | K033276 | FDA 510(k) | Class II | Active |
| Resmed S8 Prime Cpap System | K033841 | FDA 510(k) | Class II | Active |
| Pixi Pediatric Mask | K102224 | FDA 510(k) | Class II | Active |
| S7 Elite Cpap System With Somnotraxx System; Autoset Spirit Cpap System With Somnotraxx System | K030797 | FDA 510(k) | Class II | Active |
| Mirage Activa Mask | K030798 | FDA 510(k) | Class II | Active |
| EasyCare Tx 2 | K241939 | FDA 510(k) | Class II | Active |
| Res Traxx Online, Model: R14 | K083816 | FDA 510(k) | Class II | Active |
| Swift Air | K132013 | FDA 510(k) | Class II | Active |
| Autoset Spirit Cpap System | K013843 | FDA 510(k) | Class II | Active |
| Vpap Auto With Humidaire 3i | K082605 | FDA 510(k) | Class II | Active |
| S9 Vpap Tx | K123511 | FDA 510(k) | Class II | Active |
| Vpap Malibu With H2i | K062291 | FDA 510(k) | Class II | Active |
| S7 Elite And Autoset Spirit Cpap Systems With Reslink | K024191 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 12, 2016 | Z-2550-2016 | — | terminated | Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask. |
| Jan 13, 2016 | Z-0746-2016 | — | terminated | Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. |
| Apr 23, 2007 | Z-1006-2007 | — | terminated | S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke). |