Data / Medical devices / Prosthesis, Breast, Inflatable, Internal, Saline
Prosthesis, Breast, Inflatable, Internal, Saline (FWM): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM, Class 3, 21 CFR 878.3530). 4 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 8 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- FWM
- Device class
- 3
- Regulation
- 878.3530
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Costa Rica | 1 |
Makers of Prosthesis, Breast, Inflatable, Internal, Saline
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 |
|---|---|---|---|---|---|---|---|---|
| Allergan | La Aurora De Heredia, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Allergan Sales, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 1 | 2 | 1 | api.fda.gov | |
| Bimini Health Tech | Plano, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Mentor | Irving, TX, United States | Manufacturer | 0 | 1 | 2 | 0 | api.fda.gov | |
| Ssp-Simatrix Inc. | Hamilton, MT, United States | Contract manufacturer | 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.