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Data / Medical devices / Electrocardiograph, Ambulatory (Without Analysis) / United States

FDA-registered makers of Electrocardiograph, Ambulatory (Without Analysis) in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Electrocardiograph, Ambulatory (Without Analysis) (product code MWJ). 10 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Electrocardiograph, Ambulatory (Without Analysis)
Product code
MWJ
Country
United States

Makers of Electrocardiograph, Ambulatory (Without Analysis) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
BiotricityRedwood City, CA, United StatesManufacturer2July 28, 2022000api.fda.gov
Datrix LLCEscondido, CA, United StatesManufacturer2November 9, 2011000api.fda.gov
Northeast Monitoring, Inc.Maynard, MA, United StatesManufacturer2November 25, 2014000api.fda.gov
HeartbeamSanta Clara, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1December 13, 2024000api.fda.gov
KESTRA Medical Technologies, Inc.Kirkland, WA, United StatesComplaint file establishment, Specification developer1May 7, 2024000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer1July 24, 2007010api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer1August 13, 2009000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesContract manufacturer, Manufacturer1November 7, 2022000api.fda.gov
VectraCor, Inc.Totowa, NJ, United StatesSpecification developer1December 9, 2010000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer1February 26, 2016000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Clarity Design, Inc.Poway, CA, United StatesContract manufacturer0000api.fda.gov
Clearpath Medical, LLCTustin, CA, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Huxley MedicalAtlanta, GA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Specification developer0000api.fda.gov
LifeSignals, Inc.Milpitas, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer0000api.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.