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Data / Medical devices / Recorder, Magnetic Tape, Medical / United States

FDA-registered makers of Recorder, Magnetic Tape, Medical in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Recorder, Magnetic Tape, Medical (product code DSH). 17 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Recorder, Magnetic Tape, Medical
Product code
DSH
Country
United States

Makers of Recorder, Magnetic Tape, Medical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Irhythm Technologies, Inc.San Francisco, CA, United StatesSpecification developer3August 15, 2025000api.fda.gov
dms-service llcLos Angeles, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3February 22, 2017000api.fda.gov
iRhythm Technologies, Inc.Cypress, CA, United StatesManufacturer3August 15, 2025000api.fda.gov
BiotricityRedwood City, CA, United StatesManufacturer2July 29, 2020000api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer2October 24, 2002000api.fda.gov
Strados Labs Inc.Marietta, GA, United StatesManufacturer2April 27, 2022000api.fda.gov
Bardy Diagnostics, Inc.Bellevue, WA, United StatesSpecification developer1November 22, 2023000api.fda.gov
Braemar Manufacturing, LLCEagan, MN, United StatesComplaint file establishment, Manufacturer1January 4, 2018000api.fda.gov
Braemar Manufacturing, LLCSan Diego, CA, United StatesSpecification developer1January 4, 2018000api.fda.gov
Cardiac Insight, Inc.Bellevue, WA, United StatesComplaint file establishment, Manufacturer, Specification developer1March 24, 2017000api.fda.gov
Cardionet, LLCPhoenix, AZ, United StatesComplaint file establishment, Contract manufacturer1January 4, 2018000api.fda.gov
Cardionet, LLCLinwood, PA, United StatesComplaint file establishment, Contract manufacturer1January 4, 2018000api.fda.gov
Global Instrumentation, LLCE Syracuse, NY, United StatesManufacturer1December 29, 2020000api.fda.gov
Peerbridge Health, Inc.Franklin, TN, United StatesManufacturer, Specification developer1September 27, 2017000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1December 3, 1993000api.fda.gov
WearlinqRockville, MD, United StatesComplaint file establishment, Manufacturer, Specification developer1October 20, 2022000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer1August 24, 2005000api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer0000api.fda.gov
Cal-Comp UsaCarlsbad, CA, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Qualitel CorporationEverett, WA, United StatesContract manufacturer0000api.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.