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Sign in to claim this brandABBVIE INC.
United States·US-MF-000014055
Last updated May 25, 2026
Information
- Country
- United States
- Address
- 1 North Waukegan Road, North Chicago, Illinois, United States
- Website
- abbvie.com
- —
- —
- [email protected]
- Phone
- +1 800 255-5162
- PRRC Contact
- Andrew Aube
- EUDAMED SRN
- US-MF-000014055
- FDA FEI Number
- —
- DUNS Number
- 078458370
Catalogue (56)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Abb Vie J | K133096 | FDA 510(k) | Class II | Active |
| Duodopa SC Dose Calculator | 0AV945 | EUDAMED | Class IIa | Active |
| AbbVie Fixation Plate 15 FR | 062920-002 | EUDAMED | Class I | Active |
| Duodopa Dose Calculator | 0AV945 | EUDAMED | Class IIa | Active |
| SCYOVA Dose Calculator | 0AV945 | EUDAMED | Class IIa | Active |
| Produodopa Dose Calculator | 0AV945 | EUDAMED | Class IIa | Active |
Related Companies
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Authorities
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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 |
|---|---|---|---|---|
| Apr 27, 2017 | Z-2176-2017 | — | terminated | — |
| Apr 27, 2017 | Z-2178-2017 | — | terminated | PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information. |
| Apr 27, 2017 | Z-2177-2017 | — | terminated | PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information. |
| Nov 22, 2016 | Z-0786-2017 | — | terminated | AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors. |