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
| Country | Makers |
|---|---|
| United States | 31 |
| China | 6 |
| India | 6 |
| Israel | 3 |
| Taiwan | 3 |
| Finland | 3 |
| Mexico | 2 |
| Japan | 2 |
| Canada | 1 |
| Russia | 1 |
| United Kingdom | 1 |
| Ireland | 1 |
| Germany | 1 |
| Estonia | 1 |
| Belgium | 1 |
| Malaysia | 1 |
| France | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AliveCor | Mountain View, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | May 25, 2022 | 0 | 1 | 0 | api.fda.gov |
| TZ Medical, Inc. | Tualatin, OR, United States | Manufacturer, Specification developer | 4 | December 21, 2000 | 0 | 0 | 0 | api.fda.gov |
| Commwell Research And Development Ltd | kfar saba Central, Israel | Manufacturer | 3 | October 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| QT Medical, INC. Taiwan Branch | New Taipei City, Taiwan | Complaint file establishment, Manufacturer, Specification developer | 3 | December 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| SHL TeleMedicine International | Tel-Aviv Tel Aviv, Israel | Manufacturer | 3 | February 22, 2012 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 2 | September 21, 2000 | 0 | 0 | 0 | api.fda.gov |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract manufacturer, Repackager or relabeler | 2 | November 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Scottcare Corporation | Cleveland, OH, United States | Manufacturer | 2 | September 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Shandong Corecare Technology Limited | Jinan Shandong, China | Manufacturer | 2 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Biotricity | Redwood City, CA, United States | Manufacturer | 1 | December 15, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cardiocomm Solutions, Inc. | North York Ontario, Canada | Complaint file establishment, Exporter to the US, Manufacturer | 1 | February 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Datrix LLC | Escondido, CA, United States | Specification developer | 1 | August 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Healthwatch | Kfar Saba Central, Israel | Manufacturer | 1 | February 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Heartbeam | Santa Clara, CA, United States | Manufacturer | 1 | December 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Lohman Technologies, LLC | Pewaukee, WI, United States | Manufacturer | 1 | June 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Neurosoft Ltd | Ivanovo Ivanovskaya Oblast', Russia | Manufacturer | 1 | April 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Specification developer | 1 | November 7, 1991 | 0 | 0 | 0 | api.fda.gov |
| Rhythmedix | Mount Laurel, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Spacelabs Healthcare Ltd. | HERTFORD Hertfordshire, United Kingdom | Specification developer | 1 | December 4, 1997 | 0 | 0 | 0 | api.fda.gov |
| Vitalograph Ireland Ltd. | Co Clare, Ireland | Manufacturer, Specification developer | 1 | September 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| VivaQuant, Inc | Arden Hills, MN, United States | Manufacturer | 1 | February 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Monitored Caregiving | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analog Devices | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bernd Richter GMBH | Wipperfuerth North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bittium Biosignals Ltd. | KUOPIO Pohjois-Savo, Finland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eastprint Mexico S. DE R.L. DE C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fourth Frontier Technologies Private Limited | Bengaluru Karnataka, India | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Instrumentation, LLC | E Syracuse, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Irhythm Technologies, Inc. | San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaynes Technology India Limited | Mysore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KESTRA Medical Technologies, Inc. | Kirkland, WA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kitron Technologies Inc. | Windber, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals India Private Limited | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals, Inc. | Milpitas, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices, LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omron (dalian) Co., Ltd. (plant 1) | DALIAN Liaoning, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omron Healthcare Co., Ltd. | MUKO Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OMRON HEALTHCARE Co., Ltd. Matsusaka Factory | Matsusaka Mie, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qompium NV | Hasselt Limburg, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Regent Electron Suzhou Co., Ltd | Wujiang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ryder Electronics (shenzhen) Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Screentec OY | Oulu, Finland Pohjois-Pohjanmaa, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Taiwan Scientific Corporation | New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Cdmo Solutions PN Sdn. Bhd. | Penang Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Twin River Group | Trenton, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro GE Healthcare Private Ltd. | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Withings | Issy-les-Moulineaux Ile-de-France, France | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yahorng Dongguan Electronic Co Ltd | Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ya Horng Electronic Co., Ltd. | Tainan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iRhythm Technologies, Inc. | Cypress, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.