Data / Medical devices / Tissue Expander And Accessories
Tissue Expander And Accessories (LCJ): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Tissue Expander And Accessories (product code LCJ, Class U). 7 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 55 510(k) clearances under this code, the latest on January 16, 2026, and lists 7 recall events (1 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LCJ
- Device class
- U
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Costa Rica | 2 |
| Dominican Republic | 1 |
| Mexico | 1 |
| Japan | 1 |
Makers of Tissue Expander And Accessories
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mentor | Irving, TX, United States | Manufacturer | 9 | January 12, 2025 | 0 | 3 | 0 | api.fda.gov |
| Allergan Sales, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 7 | August 29, 2018 | 0 | 2 | 1 | api.fda.gov |
| Allergan | La Aurora De Heredia, Costa Rica | Manufacturer, Specification developer | 6 | August 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Tiger Aesthetics Medical-54 | Franklin, WI, United States | Complaint file establishment, Specification developer | 3 | May 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | September 18, 1985 | 0 | 1 | 0 | api.fda.gov |
| Establishment Labs S.A. | Coyol Alajuela, Costa Rica | Manufacturer | 1 | October 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| PMT Corp. | Chanhassen, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | June 26, 1985 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Dominican Republic Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSP-SiMatrix Inc. | Victor, MT, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tochigi Seiko Co., Ltd | Tochigi-shi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.