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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 7 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| S7 Elite Cp Ap System | K013909 | FDA 510(k) | Class II | Active |
| Resmed S8 Pioneer Cpap System | K041209 | FDA 510(k) | Class II | Active |
| S8 Advance | K082979 | FDA 510(k) | Class II | Active |
| Swift Fx Bella | K112489 | FDA 510(k) | Class II | Active |
| Rescontrol Ii | K040944 | FDA 510(k) | Class II | Active |
| Mirage Full Face Mask Series 2 | K023284 | FDA 510(k) | Class II | Active |
| Res Traxx Data Center | K051314 | FDA 510(k) | Class II | Active |
| Easycare Tx System (connexuns) | K113780 | FDA 510(k) | Class II | Active |
| Txcontrol | K072615 | FDA 510(k) | Class II | Active |
| Sullivan Autoset Home Nasal Cpap System | K970516 | FDA 510(k) | Class II | Active |
| Resscan | K050775 | FDA 510(k) | Class II | Active |
| Moore Park Mask | K183512 | FDA 510(k) | Class II | Active |
| Mirage Vista Mask | K031047 | FDA 510(k) | Class II | Active |
| Vpap Adapt | K051364 | FDA 510(k) | Class II | Active |
| Mirage Micro Model 16333 (s), 16334 (m&L), 16335 (lw & Xl) | K100772 | FDA 510(k) | Class II | Active |
| Mirage Quattro Full Face Mask | K063122 | FDA 510(k) | Class II | Active |
| S9 Cronulla For Her | K132606 | FDA 510(k) | Class II | Active |
| S8 Escape Ii | K080079 | FDA 510(k) | Class II | Active |
| S8 Aspen With H4i Plus | K091947 | FDA 510(k) | Class II | Active |
| Res Traxx Data Center | K053205 | FDA 510(k) | Class II | Active |
| Sullivan Autoset Portable Ii Nasal Cpap System | K970771 | FDA 510(k) | Class II | Active |
| Sullivan Vpap Ii St-A Nasal Vpap System | K974417 | FDA 510(k) | Class II | Active |
| S9 Wanda Vpap St | K140159 | FDA 510(k) | Class II | Active |
| Easycare Online | K093684 | FDA 510(k) | Class II | Active |
| AirFit N20 | K171212 | FDA 510(k) | Class II | Active |
| Prestige Cpap Flow Generator With Prestige Humidifier | K061200 | FDA 510(k) | Class II | Active |
| Mirage Micro | K071808 | FDA 510(k) | Class II | Active |
| S8 Aspen With H4i Plus | K111148 | FDA 510(k) | Class II | Active |
| Vpap Auto With H3i | K071171 | FDA 510(k) | Class II | Active |
| Mirage Fx | K102746 | FDA 510(k) | Class II | Active |
| Quattro Lt | K091129 | FDA 510(k) | Class II | Active |
| S9 Elouera | K140124 | FDA 510(k) | Class II | Active |
| Ultra Mirage Ii Mask | K050359 | FDA 510(k) | Class II | Active |
| Narval Cc | K113201 | FDA 510(k) | Class II | Active |
| Sullivan Autoset | K980721 | FDA 510(k) | Class II | Active |
| myAir | K241216 | FDA 510(k) | Class II | Active |
| Astral 100/150 | K152068 | FDA 510(k) | Class II | Active |
| Mirage Quattro | K113127 | FDA 510(k) | Class II | Active |
| Rescan | K140054 | FDA 510(k) | Class II | Active |
| Vpap S-A | K122324 | FDA 510(k) | Class II | Active |
| Vpap Tx | K113714 | FDA 510(k) | Class II | Active |
| Resscan-Pro | K082983 | FDA 510(k) | Class II | Active |
| Easycare Online | K123557 | FDA 510(k) | Class II | Active |
| S9 Greenhills | K140279 | FDA 510(k) | Class II | Active |
| Juno VPAP ST-A | K153061 | FDA 510(k) | Class II | Active |
| Sullivan Autoset Nasal Cpap System | K984428 | FDA 510(k) | Class II | Active |
| Sullivan Vpap Ii St Ventilatory Support System | K974539 | FDA 510(k) | Class II | Active |
| myAir | K250624 | FDA 510(k) | Class II | Active |
| Oxygen Diverter Valve | K033914 | FDA 510(k) | Class II | Active |
| Narval Brux | K143623 | FDA 510(k) | U | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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). |