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Data / Medical devices / Transmitters And Receivers, Electrocardiograph, Telephone

Transmitters And Receivers, Electrocardiograph, Telephone (DXH): 65 FDA-registered makers in 17 countries

65 establishments in 17 countries are registered with the FDA to make Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH, Class 2, 21 CFR 870.2920). 21 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 297 510(k) clearances under this code, the latest on February 13, 2026, and lists 5 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.

Product code
DXH
Device class
2
Regulation
870.2920
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States31
China6
India6
Israel3
Taiwan3
Finland3
Mexico2
Japan2
Canada1
Russia1
United Kingdom1
Ireland1
Germany1
Estonia1
Belgium1
Malaysia1
France1

Makers of Transmitters And Receivers, Electrocardiograph, Telephone

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
AliveCorMountain View, CA, United StatesComplaint file establishment, Manufacturer, Specification developer10May 25, 2022010api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesManufacturer, Specification developer4December 21, 2000000api.fda.gov
Commwell Research And Development Ltdkfar saba Central, IsraelManufacturer3October 18, 2017000api.fda.gov
QT Medical, INC. Taiwan BranchNew Taipei City, TaiwanComplaint file establishment, Manufacturer, Specification developer3December 6, 2023000api.fda.gov
SHL TeleMedicine InternationalTel-Aviv Tel Aviv, IsraelManufacturer3February 22, 2012000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer2September 21, 2000000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler2November 30, 2021000api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer2September 15, 2006000api.fda.gov
Shandong Corecare Technology LimitedJinan Shandong, ChinaManufacturer2October 20, 2022000api.fda.gov
BiotricityRedwood City, CA, United StatesManufacturer1December 15, 2017000api.fda.gov
Cardiocomm Solutions, Inc.North York Ontario, CanadaComplaint file establishment, Exporter to the US, Manufacturer1February 22, 2019000api.fda.gov
Datrix LLCEscondido, CA, United StatesSpecification developer1August 12, 2004000api.fda.gov
HealthwatchKfar Saba Central, IsraelManufacturer1February 17, 2015000api.fda.gov
HeartbeamSanta Clara, CA, United StatesManufacturer1December 8, 2025000api.fda.gov
Lohman Technologies, LLCPewaukee, WI, United StatesManufacturer1June 23, 2006000api.fda.gov
Neurosoft LtdIvanovo Ivanovskaya Oblast', RussiaManufacturer1April 4, 2014000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer1November 7, 1991000api.fda.gov
RhythmedixMount Laurel, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1August 5, 2014000api.fda.gov
Spacelabs Healthcare Ltd.HERTFORD Hertfordshire, United KingdomSpecification developer1December 4, 1997000api.fda.gov
Vitalograph Ireland Ltd.Co Clare, IrelandManufacturer, Specification developer1September 2, 2008000api.fda.gov
VivaQuant, IncArden Hills, MN, United StatesManufacturer1February 16, 2019000api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer0000api.fda.gov
Advanced Monitored CaregivingNew York, NY, United StatesManufacturer0000api.fda.gov
Analog DevicesWilmington, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Bernd Richter GMBHWipperfuerth North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Bittium Biosignals Ltd.KUOPIO Pohjois-Savo, FinlandComplaint file establishment, Manufacturer0000api.fda.gov
Eastprint Mexico S. DE R.L. DE C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Fourth Frontier Technologies Private LimitedBengaluru Karnataka, IndiaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer0010api.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 StatesManufacturer, Specification developer0000api.fda.gov
Global Instrumentation, LLCE Syracuse, NY, United StatesManufacturer0000api.fda.gov
Irhythm Technologies, Inc.San Francisco, CA, United StatesSpecification developer0000api.fda.gov
Innokas Medical Estonia OuTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Kaynes Technology India LimitedMysore Karnataka, IndiaContract manufacturer0000api.fda.gov
KESTRA Medical Technologies, Inc.Kirkland, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Kitron Technologies Inc.Windber, PA, United StatesContract manufacturer0000api.fda.gov
LifeSignals India Private LimitedBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
LifeSignals, Inc.Milpitas, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesManufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Omron (dalian) Co., Ltd. (plant 1)DALIAN Liaoning, ChinaContract manufacturer0000api.fda.gov
Omron Healthcare Co., Ltd.MUKO Kyoto, JapanSpecification developer0000api.fda.gov
OMRON HEALTHCARE Co., Ltd. Matsusaka FactoryMatsusaka Mie, JapanContract manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Qompium NVHasselt Limburg, BelgiumManufacturer0000api.fda.gov
Regent Electron Suzhou Co., LtdWujiang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Ryder Electronics (shenzhen) Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Screentec OYOulu, Finland Pohjois-Pohjanmaa, FinlandContract manufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesContract manufacturer0010api.fda.gov
Taiwan Scientific CorporationNew Taipei, TaiwanManufacturer0000api.fda.gov
Tecan Cdmo Solutions PN Sdn. Bhd.Penang Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Twin River GroupTrenton, NJ, United StatesManufacturer0000api.fda.gov
WIPRO GE HEALTHCARE PRIVATE Ltd.BANGALORE Karnataka, IndiaSpecification developer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov
Wipro GE Healthcare Private Ltd.Bangalore Karnataka, IndiaManufacturer0000api.fda.gov
WithingsIssy-les-Moulineaux Ile-de-France, FranceComplaint file establishment, Specification developer0000api.fda.gov
Yahorng Dongguan Electronic Co LtdGuangdong, ChinaContract manufacturer0000api.fda.gov
Ya Horng Electronic Co., Ltd.Tainan, TaiwanContract manufacturer0000api.fda.gov
iRhythm Technologies, Inc.Cypress, CA, United StatesManufacturer0000api.fda.gov

Updated February 13, 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.