Manufacturer registered with FDA
AbbVie, Inc.
Irvine, CA, United States. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 16193 registrations outside the US
- Establishments
- 2United States
Registered in 16 markets
Where regulators' registries name AbbVie, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | AbbVie, Inc. | 1 device types | — | Below |
| Australia | TGA | Registration holder | Abbvie Pty LtdAbbvie Inc · Abbvie SRL · +1 | 72 | 2006–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | AbbVie IncLifecell Corporation | 23 | — | Pure Global AI |
| Singapore | HSA | Registration holder | ABBVIE PTE. LTD. | 22 | 2006–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | ABBVIE INC.LIFECELL CORPORATION · ABBVIE CORPORATION | 17 | 1999–2025 | Pure Global AI |
| Malaysia | MDA | Registration holder | ABBVIE SDN BHD | 16 | 2022–2027 | Pure Global AI |
| Israel | AMAR | Manufacturer | LifeCell CorporationAbbVie Inc · Abbvie Inc. | 10 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | AbbVie Inc. | 8 | — | Pure Global AI |
| Argentina | ANMAT | Registration holder | ABBVIE S.A. | 7 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | ABBVIE INC. | 4 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | AbbVie Inc. | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ABBVIE INC.LIFECELL CORPORATION · LIFECELL CORPORATION INC. | 3 | 1998–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | LIFECELL CORP.LifeCell Corporation | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | LifeCell CorporationLifeCell corporation | 2 | 2018–2019 | Pure Global AI |
| Tanzania | TMDA | Registration holder | Abbvie (Pty) Limited | 2 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | LIFECELL CORPORATION | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What AbbVie, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | NovoMatrix Reconstructive Tissue Matrix | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LIFECELL CORPFDA reg. 3016823837 | Branchburg, NJ, United States | Manufacturer for export |
| LIFECELL CORP.FDA reg. 1647098 | BRANCHBURG, NJ, United States | Manufacturer for export |
Other names on FDA records
Lifecell Corporation
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2011068). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.