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Data / Medical devices / Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) / United States

FDA-registered makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) in the United States: 35 establishments

35 establishments in the United States are registered with the FDA to make Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (product code DRT). 11 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Product code
DRT
Country
United States

Makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ivy Biomedical Systems, Inc.Branford, CT, United StatesComplaint file establishment, Manufacturer5May 14, 2021000api.fda.gov
Circadia Health, Inc.El Segundo, CA, United StatesSpecification developer2February 3, 2026000api.fda.gov
Murata Vios, Inc.Woodbury, MN, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler2March 22, 2024040api.fda.gov
Criticare Technologies, Inc.Warwick, RI, United StatesManufacturer, Repackager or relabeler1May 27, 2009000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer1August 4, 2006000api.fda.gov
Nasiff Assoc., Inc.Central Square, NY, United StatesManufacturer1August 7, 1996000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesManufacturer1February 3, 2005000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer1February 3, 2005000api.fda.gov
WR Medical Electronics Co.Maplewood, MN, United StatesManufacturer1October 19, 2010000api.fda.gov
Zoe Medical, Inc.Topsfield, MA, United StatesManufacturer1January 12, 2001000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer1September 15, 2010000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Anybattery, IncRosemount, MN, United StatesManufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Biointellisense Inc.Redwood City, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Biointellisense Inc.Golden, CO, United StatesManufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.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
Engineered Medical Systems, LLCBartlett, TN, 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
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0050api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesManufacturer, Specification developer0000api.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
Scottcare CorporationCleveland, OH, United StatesManufacturer0000api.fda.gov
Sotera WirelessCarlsbad, 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.