Data / Medical devices / Binder, Breast / United States
FDA-registered makers of Binder, Breast in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Binder, Breast (product code HEF). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Binder, Breast
- Product code
- HEF
- Country
- United States
Makers of Binder, Breast in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BFFL Co LLC | Port Chester, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beocare Inc., Hudson | Hudson, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brownmed | Spirit Lake, IA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dale Medical Products, Inc. | New London, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elastic Therapy, LLC | Asheboro, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encompass Group, LLC. | McDonough, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frank Stubbs | Oxnard, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Cardiac Technology, Inc. | San Jose, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Golda, Inc. | Beachwood, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heart&core Sports And Medical LLC | Minnetonka, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lipocosm, LLC | Key Biscayne, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| My True Image MFG. | Richmond, CA, United States | 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.