AbbVie Inc
Tempe, AZ, US
AbbVie Inc appears in FDA device records in Tempe, AZ. FDA records list 7 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to AbbVie Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- AbbVie US LLCregistration
510(k) clearance history
FDA records hold 7 510(k) clearances for AbbVie Inc between 2014 and 2026. The busiest year on record is 2014, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 3 |
| 2015 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | LCJ | Substantially Equivalent | |
| K142816 | AbbVie J | KNT | Substantially Equivalent | |
| K142793 | AbbVie PEG | KNT | Unknown | |
| K142792 | AbbVie NJ | KNT | Unknown | |
| K133129 | ABBVIE NJ | KNT | Substantially Equivalent | |
| K133087 | ABBVIE PEG | KNT | Substantially Equivalent | |
| K133096 | ABB VIE J | KNT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010757606 | 3010757606 | AbbVie Inc | 1 N Waukegan Rd, North Chicago, IL 60064 US | 2026 | |
| 2032861 | 3004217756 | AbbVie Inc. | 475 W Vaughn St, Tempe, AZ 85283 US | 2026 | |
| 3011299837 | 3009751352 | AbbVie US LLC | 1 N Waukegan Rd, North Chicago, IL 60064 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2178-2017 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | 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. | Class II | Terminated | |
| Z-2177-2017 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | 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. | Class II | Terminated | |
| Z-2176-2017 | AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | Class II | Terminated | ||
| Z-0786-2017 | AbbVie PEG Kit 20 FR | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain