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Data / Medical devices / Electrocardiograph / United States

FDA-registered makers of Electrocardiograph in the United States: 55 establishments

55 establishments in the United States are registered with the FDA to make Electrocardiograph (product code DPS). 30 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Electrocardiograph
Product code
DPS
Country
United States

Makers of Electrocardiograph in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer, Specification developer8January 6, 2016000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesManufacturer, Specification developer7January 26, 2026010api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer4January 26, 2026000api.fda.gov
AliveCorMountain View, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3June 7, 2024000api.fda.gov
Prolaio Inc.Chicago, IL, United StatesManufacturer3June 11, 2020000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer3June 30, 2021010api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer, Manufacturer for export, Specification developer2August 24, 2011000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer2May 9, 2008050api.fda.gov
VectraCor, Inc.Totowa, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2August 28, 2018000api.fda.gov
Accurkardia Inc.New York, NY, United StatesManufacturer1December 22, 2025000api.fda.gov
Anybattery, IncRosemount, MN, United StatesManufacturer1May 11, 2017000api.fda.gov
Applied Cardiac Systems, Inc.Lake Forest, CA, United StatesManufacturer1March 11, 1986000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer1March 25, 2022000api.fda.gov
Cardiac Insight, Inc.Bellevue, WA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 5, 2013000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer1May 30, 2017000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler1March 5, 2014000api.fda.gov
Imedrix Diagnostics CorporationChester, NJ, United StatesSpecification developer1January 10, 2020000api.fda.gov
Infinium Medical, Inc.Largo, FL, United StatesManufacturer, Repackager or relabeler1April 25, 2012000api.fda.gov
Inmedix, Inc.Normandy Park, WA, United StatesSpecification developer1January 16, 2025000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1April 3, 2025000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesManufacturer1May 29, 2003020api.fda.gov
Midmark Corp.Blue Ash, OH, United StatesSpecification developer1March 22, 2011000api.fda.gov
Midmark CorporationVersailles, OH, United StatesManufacturer1March 22, 2011010api.fda.gov
MPSCCharlottesville, VA, United StatesManufacturer1February 28, 2018000api.fda.gov
Nasiff Assoc., Inc.Central Square, NY, United StatesContract manufacturer, Manufacturer1July 9, 1992000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1August 30, 2007000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer1August 30, 2007000api.fda.gov
Spaulding Medical, LLCMenomonee Falls, WI, United StatesManufacturer1August 12, 2015000api.fda.gov
Zbeats, IncStony Brook, NY, United StatesComplaint file establishment, Manufacturer1July 10, 2025000api.fda.gov
ZOLL Manufacturing CorporationPittsburgh, PA, United StatesManufacturer1January 28, 2019000api.fda.gov
Aidar Health, IncColumbia, MD, United StatesManufacturer, Specification developer0000api.fda.gov
Analog DevicesWilmington, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
CDR Manufacturing, Inc., DBA KeytronicOakdale, MN, United StatesContract manufacturer0000api.fda.gov
Cirtec MedicalEnfield, CT, United StatesContract manufacturer0000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Echonous, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Eko Health, Inc.Emeryville, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
HeartbeamSanta Clara, CA, United StatesManufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Ontogen Manufacturing LLCLisle, IL, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Safebeat RX Inc.San Francisco, CA, United StatesManufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesContract manufacturer0000api.fda.gov
Twin River GroupTrenton, NJ, United StatesManufacturer0000api.fda.gov
Zoe Medical, Inc.Topsfield, MA, United StatesContract manufacturer0000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer0000api.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.