Data / Medical devices / Mammary Sizer
Mammary Sizer (MRD): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Mammary Sizer (product code MRD, Class U). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on January 13, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MRD
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Costa Rica | 2 |
Makers of Mammary Sizer
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 | 5 | January 13, 2025 | 0 | 2 | 0 | api.fda.gov |
| Allergan | La Aurora De Heredia, Costa Rica | Manufacturer | 2 | June 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Allergan Sales, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 2 | June 2, 2021 | 0 | 2 | 0 | api.fda.gov |
| Establishment Labs S.A. | Coyol Alajuela, Costa Rica | Manufacturer | 1 | February 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Specialty Surgical Products, Inc. | Victor, MT, United States | Complaint file establishment, Specification developer | 1 | February 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Tiger Aesthetics Medical-57 | Franklin, WI, United States | Manufacturer | 1 | November 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ssp-Simatrix Inc. | Hamilton, MT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 13, 2025. 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.