Data / Medical devices / Button, Nasal Septal
Button, Nasal Septal (LFB): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Button, Nasal Septal (product code LFB, Class U). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on September 17, 2013, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LFB
- Device class
- U
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Dominican Republic | 1 |
Makers of Button, Nasal Septal
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 |
|---|---|---|---|---|---|---|---|---|
| Boston Medical Products, Inc. | Shrewsbury, MA, United States | Manufacturer | 1 | July 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Covidien | - Santo Domingo, Dominican Republic | Manufacturer | 1 | October 17, 1978 | 0 | 0 | 0 | api.fda.gov |
| E. Benson Hood Laboratories, Inc. | Pembroke, MA, United States | Manufacturer | 1 | May 15, 1992 | 0 | 0 | 0 | api.fda.gov |
| Freudenberg Medical, LLC | Carpinteria, CA, United States | Manufacturer | 1 | September 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Medical Innovations International | Rochester, MN, United States | Complaint file establishment, Manufacturer | 1 | November 28, 2001 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 1 | October 17, 1978 | 0 | 0 | 0 | api.fda.gov |
| Summit Medical LLC | Saint Paul, MN, United States | Manufacturer | 1 | November 24, 1998 | 0 | 1 | 0 | api.fda.gov |
Updated September 17, 2013. 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.