Data / Medical devices / Monitor, Esophageal Motility, Anorectal Motility, And Tube / United States
FDA-registered makers of Monitor, Esophageal Motility, Anorectal Motility, And Tube in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Monitor, Esophageal Motility, Anorectal Motility, And Tube
- Product code
- KLA
- Country
- United States
Makers of Monitor, Esophageal Motility, Anorectal Motility, And Tube in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medspira LLC | Minneapolis, MN, United States | Manufacturer | 2 | July 7, 2015 | 0 | 0 | 0 | api.fda.gov |
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Complaint file establishment, Manufacturer | 1 | April 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Neuraxis, Inc | Carmel, IN, United States | Complaint file establishment, Specification developer | 1 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| BIOMERICS Advanced Catheter | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Custom Solutions | Rochester, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnesota Medtec, Inc. | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resolution Medical | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rose Medical | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.