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Data / Medical devices / Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX): 95 FDA-registered makers in 19 countries

95 establishments in 19 countries are registered with the FDA to make Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX, Class 2, 21 CFR 870.1025). 56 of them have a 510(k) clearance or PMA approval on file and 17 have a recall event. The FDA has issued 431 510(k) clearances under this code, the latest on October 14, 2026, and lists 204 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
MHX
Device class
2
Regulation
870.1025
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States42
China10
Mexico8
Japan8
Germany5
India4
United Kingdom3
South Korea2
Costa Rica2
Singapore2
Finland1
Switzerland1
Bulgaria1
Brazil1
Vietnam1
Poland1
Thailand1
Malaysia1
Taiwan1

Makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer31February 6, 2026000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer21February 6, 20260110api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Repackager or relabeler, Specification developer18September 1, 2026020api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer18May 20, 2026000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer17July 24, 2026000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer16August 6, 2026000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer, Specification developer14May 20, 2026000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer, Specification developer13August 20, 20260130api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer11July 24, 2026010api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer10July 24, 2026000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer, Specification developer10November 5, 20150290api.fda.gov
Fukuda Denshi Co., Ltd.Bunkyo-ku Tokyo, JapanSpecification developer8March 16, 2015010api.fda.gov
Fukuda Denshi Usa, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer8March 16, 2015010api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler8July 24, 2026000api.fda.gov
Fukuda Denshi Co., Ltd.Shiroi-shi Chiba, JapanManufacturer7March 16, 2015000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer7July 16, 2021050api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer7July 16, 2021000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer7July 16, 2021000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer7July 16, 2021000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer5July 24, 2026010api.fda.gov
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer5February 27, 2014000api.fda.gov
Philips North America LLCAndover, MA, United StatesManufacturer, Specification developer5August 6, 20190370api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer, Manufacturer for export, Specification developer4December 8, 2017000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer4March 23, 2009000api.fda.gov
Mediana Co., Ltd.Wonju-Si, Gangwon-do, South KoreaContract manufacturer, Manufacturer3November 9, 2011000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer3July 12, 20220230api.fda.gov
Remote Diagnostic Technologies Ltd.FARNBOROUGH Hampshire, United KingdomComplaint file establishment, Manufacturer3September 18, 2020070api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer3April 13, 2022000api.fda.gov
Shenzhen Comen Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer3December 29, 2022000api.fda.gov
AliveCorMountain View, CA, United StatesComplaint file establishment, Manufacturer2January 9, 2026000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer2August 10, 2022000api.fda.gov
Nihon Kohden Digital Health Solutions, LLC.Irvine, CA, United StatesManufacturer2July 29, 2022000api.fda.gov
Schiller AGBAAR Zug, SwitzerlandContract manufacturer, Foreign private label distributor, Manufacturer2July 6, 2023010api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer2June 19, 2018000api.fda.gov
Shanghai Draeger Medical Instrument Co., Ltd.Shanghai, ChinaSpecification developer2April 24, 2026000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesComplaint file establishment, Manufacturer, Specification developer2September 4, 2018000api.fda.gov
ZOLL Manufacturing CorporationPittsburgh, PA, United StatesManufacturer2December 19, 2019000api.fda.gov
Amco International Manufacturing & Design, Inc.Brooklyn, NY, United StatesManufacturer1December 7, 2007000api.fda.gov
Contec Medical Systems Co., LtdQinhuangdao Hebei, ChinaManufacturer1June 28, 2011010api.fda.gov
Criticare Technologies, Inc.Warwick, RI, United StatesManufacturer, Repackager or relabeler1April 17, 2003010api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer1December 21, 2022000api.fda.gov
General Meditech, Inc.Shenzhen Guangdong, ChinaManufacturer1February 2, 2010000api.fda.gov
Hidalgo LimitedCambridge Cambridgeshire, United KingdomManufacturer1February 17, 2012000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler1December 13, 2019000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1September 25, 1998000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer1June 1, 2023000api.fda.gov
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)Mexicali Baja California, MexicoManufacturer1June 1, 2023000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1June 1, 2023010api.fda.gov
Medeia Group LtdSofia Sofia-Grad, BulgariaManufacturer1April 29, 2016000api.fda.gov
OBS Medical LtdCirencester Gloucestershire, United KingdomManufacturer1June 15, 2011000api.fda.gov
PacetechClearwater, FL, United StatesManufacturer1January 30, 1998000api.fda.gov
Parks Medical Electronics, Inc.Aloha, OR, United StatesManufacturer1June 2, 1995000api.fda.gov
Philips Medical Systems LtdaVarginha Minas Gerais, BrazilSpecification developer1September 2, 2025000api.fda.gov
Volcano Corporation by Volcarica S.R.L.Coyol Alajuela, Costa RicaManufacturer1April 22, 2005000api.fda.gov
WIPRO GE HEALTHCARE PRIVATE Ltd.BANGALORE Karnataka, IndiaSpecification developer1December 21, 2022000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer1April 1, 2022000api.fda.gov
Anybattery, IncRosemount, MN, United StatesManufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Bernd Richter GMBHWipperfuerth North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Dreamtech Co., Ltd.Asan-si Chungnam, South KoreaContract manufacturer0000api.fda.gov
Dreamtech Vietnam Co., LtdTu Son Ward Bac Ninh, VietnamContract manufacturer0000api.fda.gov
Defibtech BranfordBranford, CT, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0030api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
GWWGaertringen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hadleigh Health TechnologiesSausalito, CA, United StatesSpecification developer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
ItekCartago, Costa RicaContract manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
LifeSignals India Private LimitedBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
LifeSignals, Inc.Milpitas, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Murata Vios, Inc.Woodbury, MN, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Murata Vios, Private LimitedKodihalli, Bangalore Karnataka, IndiaManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Nimbleheart, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesManufacturer0000api.fda.gov
NextPhase Medical Devices Mexico LLCTIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Nicolay GMBHNAGOLD Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production CenterFukaya-Shi Saitama, JapanManufacturer0000api.fda.gov
Nihon Vinyl Cord Corporation - Kodama Second FactoryHonjo-shi Saitama, JapanContract manufacturer0000api.fda.gov
Nihon Vinyl Cord Corporation - Shimo-ongata FactoryHachioji-shi Tokyo, JapanContract manufacturer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Plexus Electronica S. de R.L. de C.V..Zapopan Jalisco, MexicoContract manufacturer0000api.fda.gov
Polimeros Formula de Tecate S.A de C.VTecate Baja California, MexicoContract manufacturer0000api.fda.gov
Sumida Electric (thailand) Co.,ltdWang Noi Phra Nakhon Si Ayutthaya, ThailandContract manufacturer0000api.fda.gov
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
Sanmina-SCI Systems Singapore Pte. Ltd.SINGAPORE North East, SingaporeContract manufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
VectraCor, Inc.Totowa, NJ, United StatesManufacturer0000api.fda.gov
VitalConnect, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
Welch Allyn De Mexico, S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov

Updated October 14, 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.