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

System, Network And Communication, Physiological Monitors (MSX): 60 FDA-registered makers in 17 countries

60 establishments in 17 countries are registered with the FDA to make System, Network And Communication, Physiological Monitors (product code MSX, Class 2, 21 CFR 870.2300). 33 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 121 510(k) clearances under this code, the latest on October 7, 2026, and lists 22 recall events (0 Class I). 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
MSX
Device class
2
Regulation
870.2300
Medical specialty
Cardiovascular
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States30
Germany5
China4
United Kingdom4
Japan3
Netherlands2
Mexico2
Sweden1
Italy1
India1
Switzerland1
Canada1
Taiwan1
Finland1
Poland1
Austria1
Brazil1

Makers of System, Network And Communication, Physiological Monitors

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer5July 31, 2025000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer4July 31, 2025000api.fda.gov
Current Health LtdEdinburgh Edinburgh, City of, United KingdomSpecification developer3August 24, 2023000api.fda.gov
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 Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer2March 30, 2026000api.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
Ascom Sweden ABGoteborg Vastra Gotaland, SwedenManufacturer1April 3, 2018000api.fda.gov
Ascom Ums SRLScandicci Firenze, ItalyManufacturer1November 23, 2018000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer1March 14, 2018000api.fda.gov
Baxter Innovations & Business Solutions Pvt. Ltd.Bangalore Karnataka, IndiaSpecification developer1August 13, 2026000api.fda.gov
Corsano Health B.V.The Hague Zuid-Holland, NetherlandsManufacturer1March 22, 2024000api.fda.gov
Cerner CorporationKansas City, MO, United StatesComplaint file establishment, Manufacturer1December 21, 2015000api.fda.gov
Corsano Health SAPlan-les-Ouates Geneve, SwitzerlandManufacturer1March 22, 2024000api.fda.gov
GlobeStar Systems, IncToronto Ontario, CanadaManufacturer1February 1, 2012000api.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 Corp.SHINJUKU-KU Tokyo, JapanSpecification developer1July 31, 2023000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer1July 31, 2023000api.fda.gov
Nihon Kohden Digital Health Solutions, LLC.Irvine, CA, United StatesManufacturer1June 5, 2025000api.fda.gov
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production CenterFukaya-Shi Saitama, JapanManufacturer1July 31, 2023000api.fda.gov
Philips Medical Systems Nederland B.V.Eindhoven Noord-Brabant, NetherlandsComplaint file establishment, Manufacturer1June 3, 2022000api.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
Taiwan Aulisa Medical Devices Technologies, Inc.Taipei City, TaiwanManufacturer1October 30, 2020000api.fda.gov
VectraCor, Inc.Totowa, NJ, United StatesManufacturer1January 30, 2015000api.fda.gov
WellinksNew Haven, CT, United StatesManufacturer1June 5, 2020000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Creative Foam Corporation dba MT. OLIVE MFGMooresville, IN, United StatesContract manufacturer0000api.fda.gov
Dynamic Ems LtdDalgety Bay Fife, United KingdomContract manufacturer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.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
GWWGaertringen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Huma Therapeutics LimitedLondon England, United KingdomManufacturer0000api.fda.gov
Key-Tech Scotland LtdDunfermline Fife, United KingdomContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Leonhard Lang GMBHINNSBRUCK Tirol, AustriaContract manufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Nicolay GMBHNAGOLD Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips Medical Systems LtdaVarginha Minas Gerais, BrazilSpecification developer0000api.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
Velcromex, S.A. De C.V.AGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer0000api.fda.gov

Updated October 7, 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.