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Sign in to claim this brandAmeda, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 8206 Cross Park Dr, Austin, TX, 78754
- Website
- ameda.com
- —
- —
- [email protected]
- Phone
- 866-992-6332
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009974348
- DUNS Number
- 078719435
Catalogue (102)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ameda Pearl Electric Breast Pump | K221576 | FDA 510(k) | Class II | Active |
| Mya Joy PLUS Breast Pump | K203570 | FDA 510(k) | Class II | Active |
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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 10, 2017 | Z-0616-2018 | — | open, classified | Two specific lots was incorrectly manufactured containing a UK power adapter. |
| Feb 12, 2015 | Z-1327-2015 | — | terminated | Devices were not sterilized |
| Feb 12, 2015 | Z-1326-2015 | — | terminated | Devices were not sterilized |