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Data / Medical devices / System, Gastrointestinal Motility (Electrical) / United States

FDA-registered makers of System, Gastrointestinal Motility (Electrical) in the United States: 10 establishments

10 establishments in the United States are registered with the FDA to make System, Gastrointestinal Motility (Electrical) (product code FFX). 7 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
System, Gastrointestinal Motility (Electrical)
Product code
FFX
Country
United States

Makers of System, Gastrointestinal Motility (Electrical) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Laborie Medical Technologies Corp.Portsmouth, NH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer8May 6, 2024010api.fda.gov
Diversatek Healthcare Inc.Highlands Ranch, CO, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler4October 3, 2019030api.fda.gov
Anx Robotica Corp.Plano, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2May 21, 2020000api.fda.gov
Covidien llcSanta Clara, CA, United StatesSpecification developer2July 21, 2023010api.fda.gov
Konsyl Pharmaceuticals, Inc.Easton, MD, United StatesManufacturer, Specification developer2November 15, 2018000api.fda.gov
CovidienPlainfield, IN, United StatesManufacturer1July 21, 2023000api.fda.gov
Medspira LLCMinneapolis, MN, United StatesManufacturer1December 5, 2025000api.fda.gov
Fermatex Vascular Technologies D.B.A. Adam SpenceWall, NJ, United StatesContract manufacturer0000api.fda.gov
Neuraxis, IncCarmel, IN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Rose MedicalGrand Rapids, MI, United StatesContract manufacturer0000api.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.