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Centese, Inc.

United Statesfrom the FDA registration address FDA FEI 3017435705

Centese, Inc. is a medical device manufacturer, with 5 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 13 Nov 2026.

Devices
5
Registrations
FDA
FDA recalls
1

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 4
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 3
  • FDA Class I 2
FDA recalls
Identifiers
  • FDA FEI 3017435705
  • DUNS 081331672

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue5

Newest first, rows 1-5 of 5

  • Thoraguard FGN-1387

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

  • Thoraguard FGS-2000

    Listed Registry: GUDID Class:I

  • Thoraguard FGS-1126

    Listed Registry: GUDID Class:I

  • Thoraguard FGS-1125

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

  • Thoraguard System Ref K181667

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

Company details

FDA FEI number
3017435705
DUNS number
081331672
Address
4156 S 52nd St, Omaha, NE, 68117
Phone
888-220-0040

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

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

  • 2021

    • 31 Aug 2021 Z-0105-2022 Class II Terminated An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. Distribution: Distribution to a single consignee located in California.

Frequently asked questions

How many devices does Centese, Inc. have in the registry?

The registry currently lists 5 devices for Centese, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Centese, Inc.'s devices?

Among its 5 most recently registered devices, Centese, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Centese, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Centese, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Centese, Inc.?

FDA recall records list 1 recall initiated by Centese, Inc., the most recent initiated on 31 Aug 2021. 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 Centese, Inc. in the registry?

The most recently registered devices listed for Centese, Inc. include Thoraguard FGN-1387, Thoraguard FGS-2000, Thoraguard FGS-1126 and Thoraguard FGS-1125.

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