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Data / Medical devices / System, Network And Communication, Physiological Monitors / United States

FDA-registered makers of System, Network And Communication, Physiological Monitors in the United States: 30 establishments

30 establishments in the United States are registered with the FDA to make System, Network And Communication, Physiological Monitors (product code MSX). 18 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
System, Network And Communication, Physiological Monitors
Product code
MSX
Country
United States

Makers of System, Network And Communication, Physiological Monitors in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer, Specification developer3July 12, 2024000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer3June 24, 2016010api.fda.gov
ActiGraph L.L.C.Pensacola, FL, United StatesManufacturer, Repackager or relabeler, Specification developer2May 9, 2024000api.fda.gov
AirStrip Technologies, Inc.San Antonio, TX, United StatesManufacturer2December 9, 2021000api.fda.gov
Intego Software, LLC D/B/A Critical AlertJacksonville, FL, United StatesManufacturer2September 30, 2025000api.fda.gov
Philips North America LLCAndover, MA, United StatesManufacturer, Specification developer2June 24, 2016010api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer2October 30, 2020010api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer1March 14, 2018000api.fda.gov
Cerner CorporationKansas City, MO, United StatesComplaint file establishment, Manufacturer1December 21, 2015000api.fda.gov
Hill-Rom, Inc.Batesville, IN, United StatesComplaint file establishment, Manufacturer1August 13, 2026000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1June 8, 2007000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer1March 13, 2019080api.fda.gov
Nihon Kohden Digital Health Solutions, LLC.Irvine, CA, United StatesManufacturer1June 5, 2025000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer1January 8, 2025000api.fda.gov
Stryker MedicalPortage, MI, United StatesComplaint file establishment, Manufacturer, Specification developer1July 11, 2013000api.fda.gov
Spok, Inc. Plano DivisionPlano, TX, United StatesManufacturer1September 13, 2011000api.fda.gov
VectraCor, Inc.Totowa, NJ, United StatesManufacturer1January 30, 2015000api.fda.gov
WellinksNew Haven, CT, United StatesManufacturer1June 5, 2020000api.fda.gov
Creative Foam Corporation dba MT. OLIVE MFGMooresville, IN, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer0000api.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.