Data / Medical devices / United States / Medical Monofilament Manufacturing
Medical Monofilament Manufacturing: FDA-registered device maker in Plymouth, MA, United States, 1 510(k) clearance
Medical Monofilament Manufacturing is registered with the FDA (registration 1226347) in Plymouth, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 14, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1226347
- FEI number
- 3002957596
- Address
- 121 Camelot Dr Ste 2, Plymouth, MA, United States, 02360
- Owner or operator
- MEDICAL MONOFILAMENT MANUFACTURING (9040501)
- Roles
- Manufacturer
- First device listed
- February 24, 2000
- Registered through
- 2026
- Brand names listed
- Fit2Walk Monofilament Sensory Screening Tool, Monofilament Sensory Screening Tool, SENSORY TESTIN NYLON FILAMENT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Esthesiometer | GXB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2015 | K143068 | Medical Monofilament Sensory Screening Toool | GXB | Substantially Equivalent | Medical Monofilament Manufacturing | accessdata.fda.gov |
Compare with other makers
Updated January 14, 2015. 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.