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Sign in to claim this brandNonin Medical, Inc.
United States·US-MF-000008228
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 13700, 1st Avenue North, Plymouth, United States
- Website
- nonin.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Dan LaBelle
- EUDAMED SRN
- US-MF-000008228
- FDA FEI Number
- 2183646
- DUNS Number
- —
Catalogue (371)
Page 1 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nonin | 6500MA | FDA UDI | Class II | Active |
| Nonin | 9600NC-6 | FDA UDI | Class II | Active |
| Nonin | X-100EC-1 | FDA UDI | Class II | Active |
| Nonin | 8004CB | FDA UDI | Class II | Active |
| Nonin | 9840AAT | FDA UDI | Class II | Active |
| Nonin | 7600TC-3 | FDA UDI | Class II | Active |
| Palmsat Handheld Oximeter | 2500, 8000SM-3 | FDA UDI | Class II | Active |
| Nonin | 6000CN | FDA UDI | Class II | Active |
| Nonin | 8000SL-3 | FDA UDI | Class II | Active |
| Nonin | 8000AP | FDA UDI | Class II | Active |
| Nonin | UNI-RA-0 | FDA UDI | Class II | Active |
| Nonin | 7600 | FDA UDI | Class II | Active |
| Nonin | LS1 PS | FDA UDI | Class II | Active |
| Nonin | 9590 | FDA UDI | Class II | Active |
| Nonin | 9570 | FDA UDI | Class II | Unknown |
| WristOx2 ® Pulse Oximeter | 3150 WB-SU | FDA UDI | Class II | Active |
| Nonin | 7500FO | FDA UDI | Class II | Active |
| Nonin | 8000AA-2 | FDA UDI | Class II | Active |
| Nonin | 8000AA | FDA UDI | Class II | Active |
| CO-Pilot™ Wireless Handheld Multi-Parameter System | H500-DK | FDA UDI | N/A | Active |
| Nonin | 8204CA | FDA UDI | Class II | Active |
| Nonin | 8000AP-3 | FDA UDI | Class II | Active |
| CO-Pilot™ Wireless Handheld Multi-Parameter System | H500, SP-BLE Kit | FDA UDI | Class II | Active |
| Nonin | 3150I | FDA UDI | Class II | Active |
| Nonin | 9500 | FDA UDI | Class II | Active |
| Nonin | 8000SS-WO2 | FDA UDI | Class II | Active |
| Nonin | 8004CB-NA | FDA UDI | Class II | Active |
| Nonin | X-100 | FDA UDI | Class II | Active |
| Nonin | LS1-9R | FDA UDI | Class II | Active |
| Nonin | 7600 | FDA UDI | Class II | Active |
| Nonin | 7500A/RJ-12 | FDA UDI | Class II | Active |
| Nonin | 3150 | FDA UDI | Class II | Active |
| CO-Pilot™ Wireless Handheld Multi-Parameter System | H500-CC | FDA UDI | Class II | Active |
| Nonin | AuxiliaryCabel | FDA UDI | Class II | Active |
| Nonin | 8003CA | FDA UDI | Class II | Active |
| Nonin | 6000CP | FDA UDI | Class II | Active |
| Nonin | 8000Q2 | FDA UDI | Class II | Active |
| Nonin | 1000USB | FDA UDI | Class II | Active |
| Nonin | 8000AA-WO | FDA UDI | Class II | Active |
| Nonin | 9840SA | FDA UDI | Class II | Active |
| Nonin | 8500M | FDA UDI | Class II | Active |
| Nonin | 9700 | FDA UDI | Class II | Active |
| Nonin | LS1 | FDA UDI | Class II | Active |
| CO-Pilot™ Wireless Handheld Multi-Parameter System | H500-PS | FDA UDI | Class II | Active |
| Nonin | 8000SS-3 | FDA UDI | Class II | Active |
| Nonin | 8000J-WO | FDA UDI | Class II | Active |
| Palmsat Handheld Oximeter | 2500,8000SM | FDA UDI | Class II | Active |
| Nonin | 7600 | FDA UDI | Class II | Active |
| Nonin | UNI-EXT-1 | FDA UDI | Class II | Active |
| Nonin | 7500BP | FDA UDI | Class II | Active |
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FDA Recalls (4)
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 |
|---|---|---|---|---|
| Sep 29, 2016 | Z-1690-2017 | — | terminated | Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature. |
| Nov 25, 2014 | Z-0901-2015 | — | terminated | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported. |
| Oct 23, 2009 | Z-0458-2010 | — | terminated | A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient. |
| Oct 11, 2007 | Z-0843-2008 | — | terminated | Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500. |