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Sign in to claim this brandInsulet Corporation
United States·US-MF-000007948
Last updated September 17, 2026
About
Simplify life with our tubeless, waterproof insulin pod. Omnipod® delivers continuous insulin with no injections. Discover if Omnipod® is right for you.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 100, Nagog Park, Acton - Massachusetts, United States
- Website
- www.omnipod.com
- —
- facebook.com/myomnipod
- [email protected]
- Phone
- +19786007000
- PRRC Contact
- Thom McNamara
- EUDAMED SRN
- US-MF-000007948
- FDA FEI Number
- 3014585508
- DUNS Number
- —
Catalogue (59)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Omnipod Insulin Management System | 18916-5S | EUDAMED | Class IIb | Active |
| PodPals Adhesive Overlay | POD-X9-999 | EUDAMED | Class I | Active |
| Omnipod Insulin Management System | PDM-FRT400 | EUDAMED | Class IIb | Active |
| Omnipod Insulin Management System | 18900-6G | EUDAMED | Class IIb | Active |
| Omnipod Insulin Management System | 18916-5M | EUDAMED | Class IIb | Active |
| Omnipod Insulin Management System | 18916-5E | EUDAMED | Class IIb | Active |
| PodPals Adhesive Overlay | POD-X9-999NS | EUDAMED | Class I | Active |
| Omnipod Insulin Management System | 18900-5M | EUDAMEDFDA 510(k) | Class IIb | Active |
| Omnipod Insulin Management System | 18916-5D | EUDAMED | Class IIb | Active |
Related Companies
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Importers
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Authorities
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FDA Recalls (7)
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 |
|---|---|---|---|---|
| Dec 18, 2018 | Z-0347-2020 | — | terminated | There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history. |
| Nov 2, 2015 | Z-0393-2016 | — | terminated | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. |
| Nov 2, 2015 | Z-0394-2016 | — | terminated | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. |
| Jul 13, 2015 | Z-2485-2015 | — | terminated | OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin |
| Jul 13, 2015 | Z-2484-2015 | — | terminated | OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin |
| Sep 27, 2013 | Z-0165-2014 | — | terminated | Alcohol Prep Pads contained within the kit are not properly labeled. |
| Sep 27, 2013 | Z-0166-2014 | — | terminated | Alcohol Prep Pads contained within the kit are not properly labeled. |