Data / Medical devices / Esthesiometer / United States
FDA-registered makers of Esthesiometer in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Esthesiometer (product code GXB). 1 has 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
- Esthesiometer
- Product code
- GXB
- Country
- United States
Makers of Esthesiometer in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medical Monofilament Manufacturing | Plymouth, MA, United States | Manufacturer | 1 | January 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| Alimed, LLC | Dedham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Darco International, Inc. | Huntington, WV, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabrication Ent., Inc. | Elmsford, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Health Supply, LLC. | Cedarburg, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richardson Products, Inc. | Frankfort, IL, United States | Manufacturer, Repackager or relabeler | 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.