Data / Medical devices / Tissue Expander And Accessories / United States
FDA-registered makers of Tissue Expander And Accessories in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Tissue Expander And Accessories (product code LCJ). 5 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Tissue Expander And Accessories
- Product code
- LCJ
- Country
- United States
Makers of Tissue Expander And Accessories in the United States
| 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 |
| 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 |
| PMT Corp. | Chanhassen, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | June 26, 1985 | 0 | 0 | 0 | api.fda.gov |
| SSP-SiMatrix Inc. | Victor, MT, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.