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Data / Medical devices / System, Measurement, Blood-Pressure, Non-Invasive / United States

FDA-registered makers of System, Measurement, Blood-Pressure, Non-Invasive in the United States: 87 establishments

87 establishments in the United States are registered with the FDA to make System, Measurement, Blood-Pressure, Non-Invasive (product code DXN). 45 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.

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Device
System, Measurement, Blood-Pressure, Non-Invasive
Product code
DXN
Country
United States

Makers of System, Measurement, Blood-Pressure, Non-Invasive in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
A&D Engineering, Inc.Duluth, GA, United StatesComplaint file establishment, Remanufacturer, Repackager or relabeler14October 6, 2022000api.fda.gov
A and D Engineering, Inc.Hoschton, GA, United StatesContract manufacturer, Repackager or relabeler13April 24, 2019000api.fda.gov
A&d Engineering, Inc.Ann Arbor, MI, United StatesComplaint file establishment, Remanufacturer, Repackager or relabeler12April 24, 2019010api.fda.gov
Kaz USA, Inc., A Helen of Troy CompanyMarlborough, MA, United StatesComplaint file establishment, Specification developer8August 21, 2024000api.fda.gov
Kaz USA, Inc., A Helen of Troy CompanyOlive Branch, MS, United StatesManufacturer, Repackager or relabeler, Specification developer7August 21, 2024000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer6October 24, 2023000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer5August 21, 2024000api.fda.gov
Caretaker MedicalCharlottesville, VA, United StatesManufacturer, Specification developer4March 30, 2022000api.fda.gov
Higi SH LLCChicago, IL, United StatesSpecification developer4October 10, 2017000api.fda.gov
IMPILO, Inc.Philadelphia, PA, United StatesContract manufacturer, Repackager or relabeler4August 29, 2022000api.fda.gov
Metene LimitedCity of Industry, CA, United StatesSpecification developer4December 20, 2023000api.fda.gov
Prevounce Health, IncIndianapolis, IN, United StatesComplaint file establishment, Specification developer3March 9, 2021000api.fda.gov
Suntech Medical, Inc.Morrisville, NC, United StatesManufacturer3July 6, 2016020api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesComplaint file establishment, Manufacturer, Specification developer3November 2, 2012020api.fda.gov
Amarigo IncLos Angeles, CA, United StatesManufacturer2December 1, 2022000api.fda.gov
Carematix Inc.Chicago, IL, United StatesManufacturer, Specification developer2November 28, 2012000api.fda.gov
D. E. Hokanson, Inc.Bellevue, WA, United StatesContract manufacturer, Manufacturer2March 6, 1991000api.fda.gov
Impilo PhoenixPhoenix, AZ, United StatesContract manufacturer, Repackager or relabeler2August 29, 2022000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer2July 12, 2020020api.fda.gov
Pursuant HealthAlpharetta, GA, United StatesManufacturer, Remanufacturer, Specification developer2January 4, 2024000api.fda.gov
Twin River GroupTrenton, NJ, United StatesManufacturer2March 14, 2019000api.fda.gov
Zoe Medical, Inc.Topsfield, MA, United StatesContract manufacturer, Manufacturer2April 9, 2010010api.fda.gov
AnriwellRiverside, CA, United StatesRepackager or relabeler, Specification developer1April 22, 2016000api.fda.gov
BodytraceSan Jose, CA, United StatesSpecification developer1September 16, 2019000api.fda.gov
Cardiocommand, Inc.Tampa, FL, United StatesComplaint file establishment, Contract manufacturer1July 31, 2008000api.fda.gov
Care 365, LLCMonsey, NY, United StatesManufacturer, Specification developer1January 23, 2002000api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesComplaint file establishment, Specification developer1October 4, 2024000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1February 15, 2011000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer1February 18, 2011000api.fda.gov
ENDOTRONIX (Naperville)Naperville, IL, United StatesManufacturer for export, Repackager or relabeler1March 3, 2005000api.fda.gov
Global Instrumentation, LLCE Syracuse, NY, United StatesManufacturer1May 24, 2017000api.fda.gov
Healthchek Network, LLCLake Charles, LA, United StatesSpecification developer1April 12, 2016000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1March 25, 1999000api.fda.gov
Intercare DX, Inc.Torrance, CA, United StatesManufacturer, Specification developer1January 23, 2002000api.fda.gov
LD Technology LLCMiami, FL, United StatesManufacturer, Specification developer1May 15, 2020000api.fda.gov
Med-Linket CorpAlhambra, CA, United StatesManufacturer1August 2, 2019000api.fda.gov
Medtronic Care Management ServicesLafayette, CO, United StatesComplaint file establishment, Specification developer1August 25, 2009000api.fda.gov
Murata Vios, Inc.Woodbury, MN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1January 23, 2025000api.fda.gov
Nasiff Assoc., Inc.Central Square, NY, United StatesManufacturer1February 20, 1998000api.fda.gov
Optum Distribution Center, LLCMarietta, GA, United StatesManufacturer1October 7, 2014000api.fda.gov
Pyrames IncCupertino, CA, United StatesManufacturer1September 29, 2023010api.fda.gov
PharmaSmart International, LLCRochester, NY, United StatesComplaint file establishment, Specification developer1May 1, 2007000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer1October 11, 2011000api.fda.gov
Sutter HealthSacramento, CA, United StatesRepackager or relabeler, Specification developer1November 28, 2023000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesContract manufacturer, Manufacturer1September 26, 2014000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Aidar Health, IncColumbia, MD, United StatesManufacturer, Specification developer0000api.fda.gov
ALOM Technologies CorporationIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Anybattery, IncRosemount, MN, United StatesManufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesManufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Csa Service Solutions, LLCWilmington, OH, United StatesContract manufacturer0000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Flash GlobalLockbourne, OH, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
IMPILO - PHL KubachPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Infinium Medical, Inc.Largo, FL, United StatesManufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Midwest Products And EngineeringMilwaukee, WI, United StatesContract manufacturer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0010api.fda.gov
Nonin Medical, Inc.Plymouth, MN, United StatesManufacturer0000api.fda.gov
Parks Medical Electronics, Inc.Aloha, OR, United StatesManufacturer0000api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0020api.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
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Unika Health Inc.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
W.A. Baum Co., Inc.Copiague, NY, United StatesManufacturer0000api.fda.gov
Wellvii IncPalm Beach Gardens, FL, United StatesSpecification developer0000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
iHealth Labs, Inc.Sunnyvale, CA, 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.