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Reynolds Medical, Ltd.

Also registered as Del Mar Reynolds Medical, Ltd.

Country not established

Devices
16
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Reynolds Medical, Ltd. makes

Reynolds Medical, Ltd. manufactures cardiac monitoring devices, including portable and wearable electrocardiograph (ECG) recorders, Holter monitors, event recorders, and systems for ECG data collection and analysis. Their products include compact ECG recorders like the LIFECARD CF and LIFECARD CF 7-Day, trans-telephonic ECG receiving systems such as the EVENTSTATION, and Holter analyzers like the PATHFINDER 700. Additional offerings include information management systems (e.g., CARDIONAVIGATOR), tape-based ECG recorders (e.g., TRACKER-2), and specialized ECG storage solutions (e.g., E-RAM).

The company’s devices are classified under Class II regulatory categories in the US and are listed in the FDA 510(k) database as authorised medical devices. Their portfolio is regulated under US jurisdiction, with no additional international registries mentioned. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

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  • Sentinel Ref K062397

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hrv Tools Ref K040313

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardionavigator + Ref K051960

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lifecard Cf Compact Recorder Ref K001025

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardionavigator Information Management System Ref K011345

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardiocall Cardiac Event Recorder Ref K972649

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardiocollect Portable Electrocardiograph Ref K013367

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pathfinder 700 Holter Analyzer Ref K951902

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Eventstation Ecg Trans-Telephonic Receiving System Ref K991211

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tracker 2/Tracker 3 Holter Recorder Ref K943278

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardiodirect, Models 12M, 12I, 12S Ref K024283

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • E-Ram Ref K884126

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pathfinder 3, Auto Surveyor And Surveyor Ref K871344

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Voyager 12 Ref K062469

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lifecard Cf 7 Day Ref K011837

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tracker-2 Channel Ecg Tape Recorder Ref K821516

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-16 of 16

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 2
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2017

    • 14 Apr 2017 Z-2093-2017 Class II Terminated Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient. Distribution: US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom. Submission number: K113051
    • 8 Feb 2017 Z-1460-2017 Class II Terminated Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms. Distribution: Worldwide Distribution - US nationwide and internationally in the following countries: BOLIVIA, CANADA, CHINA, ECUADOR,…
      Full distribution text Worldwide Distribution - US nationwide and internationally in the following countries: BOLIVIA, CANADA, CHINA, ECUADOR, FRANCE, IRELAND, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PANAMA, PERU, POLAND, UNITED KINGDOM.
      Submission number: K113051

  • 2015

    • 5 Mar 2015 Z-1458-2015 Class II Terminated Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient. Distribution: Worldwide Distribution-US including the states of Louisiana, North Carolina, and Washington and the countries of…
      Full distribution text Worldwide Distribution-US including the states of Louisiana, North Carolina, and Washington and the countries of Argentina, Brazil, China, Colombia, Ecuador, Finland, Great Britain, India, Libya, Mexico, Nicaragua, Oman, Philippines, Saudi Arabia, Slovakia, Sri Lanka, United Arab Emirates, and Vietnam.
      Submission number: K112729

Frequently asked questions

How many devices does Reynolds Medical, Ltd. have in the registry?

The registry currently lists 16 devices for Reynolds Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Reynolds Medical, Ltd.'s devices?

Among its 16 most recently registered devices, Reynolds Medical, Ltd. has devices listed in FDA 510(k) (16 devices).

What risk classes do Reynolds Medical, Ltd.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Reynolds Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Reynolds Medical, Ltd.?

FDA recall records list 3 recalls initiated by Reynolds Medical, Ltd., the most recent initiated on 14 Apr 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Reynolds Medical, Ltd. in the registry?

The most recently registered devices listed for Reynolds Medical, Ltd. include SENTINEL, HRV TOOLS, CARDIONAVIGATOR + and LIFECARD CF COMPACT RECORDER.

Generated automatically from registry data and not verified by a human reviewer.