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Data / Medical devices / Computer, Diagnostic, Programmable / United States

FDA-registered makers of Computer, Diagnostic, Programmable in the United States: 75 establishments

75 establishments in the United States are registered with the FDA to make Computer, Diagnostic, Programmable (product code DQK). 42 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United StatesWatch these makers
Device
Computer, Diagnostic, Programmable
Product code
DQK
Country
United States

Makers of Computer, Diagnostic, Programmable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesComplaint file establishment, Manufacturer, Specification developer34September 17, 2026000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer, Manufacturer for export, Repackager or relabeler, Specification developer29September 17, 2026010api.fda.gov
Biosense Webster, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer15February 20, 2026000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Specification developer15August 21, 2026000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer14February 24, 2026000api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer, Manufacturer for export11September 25, 2025000api.fda.gov
Irvine Biomedical. Inc.Irvine, CA, United StatesManufacturer9August 9, 2024000api.fda.gov
Biosense Webster, Inc.Irvine, CA, United StatesManufacturer8February 20, 2026000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Specification developer8August 21, 2026010api.fda.gov
Centerline BiomedicalCleveland, OH, United StatesManufacturer8October 1, 2026011api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer8January 17, 2025000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler6December 12, 2024000api.fda.gov
Boston Scientific CorporationWaltham, MA, United StatesSpecification developer5August 29, 2024000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesManufacturer, Specification developer5December 13, 2023030api.fda.gov
Irhythm Technologies, Inc.San Francisco, CA, United StatesSpecification developer5February 15, 2023000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer4December 12, 2024010api.fda.gov
Abbott MedicalWestford, MA, United StatesManufacturer, Specification developer3April 30, 2022000api.fda.gov
AliveCorMountain View, CA, United StatesComplaint file establishment, Manufacturer3April 26, 2022000api.fda.gov
Merge Healthcare IncorporatedHartland, WI, United StatesManufacturer3June 21, 20240150api.fda.gov
Cortex, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer2May 28, 2025000api.fda.gov
Imricor Medical SystemsBurnsville, MN, United StatesComplaint file establishment, Manufacturer2June 30, 2026000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer2July 18, 2012000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer2July 18, 2012020api.fda.gov
Rhythm Ai IncLa Jolla, CA, United StatesManufacturer2July 26, 2024000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesContract manufacturer, Manufacturer2April 19, 2011060api.fda.gov
Vektor Medical, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2December 4, 2025000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer2July 30, 2018000api.fda.gov
Amphenol DC ElectronicsSan Jose, CA, United StatesManufacturer1October 6, 2015000api.fda.gov
Analytics For Life Inc.Bethesda, MD, United StatesManufacturer1July 26, 2026000api.fda.gov
Apn Health IncBrookfield, WI, United StatesManufacturer1February 23, 2016010api.fda.gov
CardionxtWestminster, CO, United StatesComplaint file establishment, Manufacturer1August 16, 2021000api.fda.gov
Catheter Precision, IncorporatedFort Mill, SC, United StatesComplaint file establishment, Manufacturer1September 14, 2020000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1June 9, 2023000api.fda.gov
Intelerad USARaleigh, NC, United StatesComplaint file establishment, Manufacturer1December 20, 2012000api.fda.gov
LumedxRaleigh, NC, United StatesComplaint file establishment, Manufacturer1December 20, 2012000api.fda.gov
Medtronic, Inc.Billerica, MA, United StatesManufacturer, Manufacturer for export1March 8, 2024000api.fda.gov
Northeast Monitoring, Inc.Maynard, MA, United StatesManufacturer1April 19, 1995000api.fda.gov
Premier Heart, LLCPort Washington, NY, United StatesManufacturer1March 21, 2000000api.fda.gov
Safebeat RX Inc.San Francisco, CA, United StatesManufacturer1February 6, 2026000api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer1September 22, 2004000api.fda.gov
Stereotaxis, Inc.Saint Louis, MO, United StatesSpecification developer1January 21, 2010000api.fda.gov
VectraCor, Inc.Totowa, NJ, United StatesSpecification developer1July 16, 1996000api.fda.gov
Accurkardia Inc.New York, NY, United StatesManufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Cardiac Insight, Inc.Bellevue, WA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Clearpath Medical, LLCTustin, CA, United StatesContract manufacturer0000api.fda.gov
Conmed CorporationUtica, NY, United StatesContract manufacturer0000api.fda.gov
Cardinal HealthWabasha, MN, United StatesContract manufacturer0000api.fda.gov
Dedicated Computing LLCWaukesha, WI, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
FUJIFILM Healthcare Americas CorporationDurham, NC, United StatesManufacturer0000api.fda.gov
Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesBuffalo, NY, United StatesContract manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
LEAD-LOK, INC. d.b.a Nissha Medical TechnologiesSandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Neenah, WI, 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
Phillips-Medisize Costa Mesa LLCCosta Mesa, CA, United StatesContract manufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Scimage, Inc.Los Altos, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
Spectrum Assembly Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
TD SynnexGroveport, OH, United StatesContract manufacturer0000api.fda.gov
Technical Services For Electronics, Inc.Jackson, MN, United StatesContract manufacturer0000api.fda.gov
TOUCHPOINT MEDICAL, Inc.Odessa, FL, United StatesContract manufacturer0000api.fda.gov
Zurich Medical IncPlymouth, MN, United StatesManufacturer0000api.fda.gov
iRhythm Technologies, Inc.Cypress, 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.