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Sonendo, Inc.

United StatesFDA applicant, unverified FDA FEI 3010817521

Sonendo, Inc. is a medical device manufacturer, with 200 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 3 FDA recalls as of 13 Nov 2026.

Devices
200
Registrations
FDA
FDA recalls
32 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 191
  • FDA 510(k) 9

A device listed in two registries counts in both.

Device classes
  • FDA Class I 149
  • FDA Class II 51
FDA recalls
Identifiers
  • FDA FEI 3010817521
  • DUNS 828894373

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue200

Newest first, rows 1-50 of 200

Search and filter all 200 devices
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Rows 1-50 of 200

Showing 1-50 of 200

Company details

FDA FEI number
3010817521
DUNS number
828894373
Address
26061 Merit Circle, Laguna Hills, CA, 92653
Phone
8447663636

FDA recalls3

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 1
  • 2020 0
  • 2021 0
  • 2022 2
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2022

    • 14 Oct 2022 Z-0233-2023 Class II Ongoing Procedure Instruments with erroneous unit carton labels. Distribution: Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada. Submission number: K190359
    • 14 Oct 2022 Z-0234-2023 Class II Ongoing Procedure Instruments with erroneous unit carton labels. Distribution: Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada. Submission number: K190359

  • 2019

    • 23 Oct 2019 Z-2162-2020 Class II Terminated The console would continue to run for extended period when the foot pedal was released. Distribution: U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE,…
      Full distribution text U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE, KY, VT, ND, NJ, DC, LA, NY, MA, VA, MN, SC, MD, PA, NH, NV, NE, OR, MS, WI, AK, IA. No foreign consignees.
      Submission number: K190359

Frequently asked questions

How many devices does SONENDO, INC. have in the registry?

The registry currently lists 200 devices for SONENDO, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list SONENDO, INC.'s devices?

Among its 50 most recently registered devices, SONENDO, INC. has devices listed in FDA GUDID (50 devices).

What risk classes do SONENDO, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for SONENDO, INC.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for SONENDO, INC.?

FDA recall records list 3 recalls initiated by SONENDO, INC., the most recent initiated on 14 Oct 2022. 2 of them are 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 SONENDO, INC. in the registry?

The most recently registered devices listed for SONENDO, INC. include FlowLogic Agile FG-016-00001-03, FlowLogic Agile FG-016-00001-33, FlowLogic Agile FG-016-00001-63 and FlowLogic Assert FG-016-00007-03.

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