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Data / Medical devices / Detector And Alarm, Arrhythmia / United States

FDA-registered makers of Detector And Alarm, Arrhythmia in the United States: 54 establishments

54 establishments in the United States are registered with the FDA to make Detector And Alarm, Arrhythmia (product code DSI). 19 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 3, 2026.

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Device
Detector And Alarm, Arrhythmia
Product code
DSI
Country
United States

Makers of Detector And Alarm, Arrhythmia in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic, Inc.Mounds View, MN, United StatesManufacturer, Specification developer4September 24, 2019010api.fda.gov
Infobionic, Inc.Burleson, TX, United StatesComplaint file establishment, Specification developer3July 29, 2025000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer3November 17, 2011030api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer3March 3, 20110180api.fda.gov
Medicomp, Inc.Melbourne, FL, United StatesManufacturer, Specification developer2January 10, 2018000api.fda.gov
Philips North America LLCAndover, MA, United StatesComplaint file establishment, Manufacturer, Specification developer2November 17, 2011070api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer2December 12, 2014020api.fda.gov
Braemar Manufacturing, LLCEagan, MN, United StatesComplaint file establishment, Manufacturer1July 22, 2016000api.fda.gov
Boston Scientific Cardiac Diagnostic Technologies, Inc.Rochester, MN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1January 23, 2026000api.fda.gov
Braemar Manufacturing, LLCSan Diego, CA, United StatesSpecification developer1July 22, 2016000api.fda.gov
Cardionet, LLCPhoenix, AZ, United StatesComplaint file establishment, Contract manufacturer1July 22, 2016000api.fda.gov
Cardionet, LLCLinwood, PA, United StatesComplaint file establishment, Contract manufacturer1July 22, 2016000api.fda.gov
Criticare Technologies, Inc.Warwick, RI, United StatesManufacturer, Repackager or relabeler1March 16, 1989000api.fda.gov
Datrix LLCEscondido, CA, United StatesSpecification developer1August 1, 2011000api.fda.gov
Global Instrumentation, LLCE Syracuse, NY, United StatesManufacturer1April 22, 2016000api.fda.gov
Irhythm Technologies, Inc.San Francisco, CA, United StatesSpecification developer1October 30, 2024000api.fda.gov
Life Sensing Instruments, Inc.Charlotte, NC, United StatesManufacturer1March 19, 1990000api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesManufacturer1June 13, 2011000api.fda.gov
iRhythm Technologies, Inc.Cypress, CA, United StatesManufacturer1October 30, 2024010api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Applied Cardiac Systems, Inc.Lake Forest, CA, United StatesManufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, 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
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 developer0010api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.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
LEAD-LOK, INC. d.b.a Nissha Medical TechnologiesSandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Medtronic, Inc.Tempe, AZ, United StatesManufacturer0000api.fda.gov
Murata Vios, Inc.Woodbury, MN, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Pertech Industries, IncRiverton, WY, United StatesManufacturer for export0000api.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
VitalConnect, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
VivaQuant, IncArden Hills, MN, United StatesManufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer0000api.fda.gov
ZOLL Manufacturing CorporationPittsburgh, PA, 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.