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Data / Medical devices / Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) / United States

FDA-registered makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) in the United States: 74 establishments

74 establishments in the United States are registered with the FDA to make Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (product code MWI). 43 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 3, 2026.

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Device
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Product code
MWI
Country
United States

Makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer7August 12, 2026000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer7September 30, 2021030api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Manufacturer6January 14, 2022020api.fda.gov
Infinium Medical, Inc.Largo, FL, United StatesManufacturer5February 6, 2015010api.fda.gov
Invivo CorporationOrlando, FL, United StatesSpecification developer5September 30, 20210180api.fda.gov
CovidienLafayette, CO, United StatesManufacturer, Specification developer4November 14, 2016020api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer, Repackager or relabeler4December 23, 2015000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesComplaint file establishment, Manufacturer, Specification developer4December 20, 2024000api.fda.gov
Analog DevicesWilmington, MA, United StatesComplaint file establishment, Manufacturer3October 16, 2026000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer3June 26, 2024000api.fda.gov
AirStrip Technologies, Inc.San Antonio, TX, United StatesManufacturer3January 18, 2015000api.fda.gov
Flash GlobalLockbourne, OH, United StatesContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler3August 8, 2018000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler3April 25, 2024000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer3April 25, 2024020api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer3April 25, 2024000api.fda.gov
Iradimed CorporationOrlando, FL, United StatesManufacturer, Specification developer3March 29, 2019000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer2July 14, 2017000api.fda.gov
Etiometry Inc.Dedham, MA, United StatesManufacturer2November 25, 2020000api.fda.gov
Hill-Rom, Inc.Raleigh, NC, United StatesComplaint file establishment, Manufacturer2January 16, 2026000api.fda.gov
LD Technology LLCMiami, FL, United StatesManufacturer, Repackager or relabeler, Specification developer2April 27, 2020000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer2March 27, 2019020api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer2December 14, 2015010api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer2September 11, 2019000api.fda.gov
Zoe Medical, Inc.Topsfield, MA, United StatesManufacturer2May 8, 2015000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer1February 18, 2014000api.fda.gov
Advanced Monitored CaregivingNew York, NY, United StatesManufacturer1September 27, 2024000api.fda.gov
Aidar Health, IncColumbia, MD, United StatesManufacturer, Specification developer1February 6, 2021000api.fda.gov
Ambient Clinical AnalyticsRochester, MN, United StatesManufacturer1April 2, 2015000api.fda.gov
Bayer Medical Care Inc.Indianola, PA, United StatesComplaint file establishment, Specification developer1September 29, 2004020api.fda.gov
Criticare Technologies, Inc.Warwick, RI, United StatesManufacturer, Repackager or relabeler1August 1, 2001000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer1September 25, 2019000api.fda.gov
Eko Health, Inc.Emeryville, CA, United StatesManufacturer1January 15, 2020000api.fda.gov
Happy HealthAustin, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1September 24, 2024000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler1May 1, 2012000api.fda.gov
Medwand Solutions, IncRsm, CA, United StatesSpecification developer1July 22, 2022000api.fda.gov
Medical Informatics Corp.Houston, TX, United StatesManufacturer1May 26, 2015000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1September 16, 2003000api.fda.gov
Ordinatrum HealthTustin, CA, United StatesManufacturer1June 6, 2023000api.fda.gov
Scimage, Inc.Los Altos, CA, United StatesRepackager or relabeler, Specification developer1September 8, 2017000api.fda.gov
Talis Clinical LLCRichfield, OH, United StatesManufacturer1April 1, 2024000api.fda.gov
Unika Health Inc.Sunnyvale, CA, United StatesSpecification developer1February 3, 2025000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer1March 9, 2021000api.fda.gov
iHealth Labs, Inc.Sunnyvale, CA, United StatesManufacturer1February 3, 2025000api.fda.gov
Anybattery, IncRosemount, MN, United StatesManufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
ActiGraph L.L.C.Pensacola, FL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Avnet, Inc. (Avnet Logistics)Chandler, AZ, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Creative Foam Corporation dba MT. OLIVE MFGMooresville, IN, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0010api.fda.gov
Ever Ppe IncSealy, TX, United StatesContract manufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
FabriteqKnoxville, TN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Gregory MFG., Inc.Holyoke, MA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Ivy Biomedical Systems, Inc.Branford, CT, United StatesManufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions Jasper, Inc.Jasper, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nimbleheart, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Nihon Kohden Digital Health Solutions, LLC.Irvine, CA, United StatesManufacturer0000api.fda.gov
Polyzen, LLCApex, NC, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer0000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov

Updated November 3, 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.