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

FDA-registered makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in the United States: 42 establishments

42 establishments in the United States are registered with the FDA to make Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX). 27 have a 510(k) clearance or PMA approval on file and 11 have a recall event. FDA data exported November 2, 2026.

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Device
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Product code
MHX
Country
United States

Makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer21February 6, 20260110api.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 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
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer7July 16, 2021050api.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
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer3July 12, 20220230api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer3April 13, 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
Sotera WirelessCarlsbad, CA, United StatesManufacturer2June 19, 2018000api.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
Criticare Technologies, Inc.Warwick, RI, United StatesManufacturer, Repackager or relabeler1April 17, 2003010api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer1December 21, 2022000api.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
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1June 1, 2023010api.fda.gov
PacetechClearwater, FL, United StatesManufacturer1January 30, 1998000api.fda.gov
Parks Medical Electronics, Inc.Aloha, OR, United StatesManufacturer1June 2, 1995000api.fda.gov
Anybattery, IncRosemount, MN, United StatesManufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, 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
Hadleigh Health TechnologiesSausalito, CA, United StatesSpecification developer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract 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
Nimbleheart, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesManufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract 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

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.