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Topcon Medical Systems, Inc.

United StatesFDA applicant, unverified

Devices
11
FDA recalls
31 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue11

Newest first, rows 1-11 of 11

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Rows 1-11 of 11

FDA recalls3

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

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

  • 2024

    • 17 Sep 2024 Z-0362-2025 Class II Ongoing The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided Distribution: US Nationwide distribution. Submission number: K232828

  • 2020

    • 18 Dec 2020 Z-0952-2021 Class II Terminated Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record Distribution: AZ, MO, NC, NY, PA, TX

  • 2019

    • 6 Mar 2019 Z-1138-2019 Class II Terminated When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used. Distribution: Nationwide Submission number: K171370

Frequently asked questions

How many devices does Topcon Medical Systems, Inc. have in the registry?

The registry currently lists 11 devices for Topcon Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Topcon Medical Systems, Inc.'s devices?

Among its 11 most recently registered devices, Topcon Medical Systems, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Topcon Medical Systems, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Topcon Medical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Topcon Medical Systems, Inc.?

FDA recall records list 3 recalls initiated by Topcon Medical Systems, Inc., the most recent initiated on 17 Sep 2024. 1 of them is recorded as ongoing. 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 Topcon Medical Systems, Inc. in the registry?

The most recently registered devices listed for Topcon Medical Systems, Inc. include TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM, SYNERGY ODM, SYNERGY and SLIT LAMP SL-2G.

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