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Freudenberg Medical LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000023823 FEI 3008581151

Devices
354
Registrations
EUDAMEDFDA
FDA recalls
42 ongoing

Catalogue354

Newest first, rows 151-200 of 354

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Rows 151-200 of 354

Showing 151-200 of 354

Company details

EUDAMED SRN
US-MF-000023823
FDA FEI number
3008581151
DUNS number
120981337
EUDAMED status
Active
EUDAMED registered name
Freudenberg Medical LLC
EUDAMED abbreviated name
FMed-Carp
Registered address
1110, Mark Avenue, 93013, CARPINTERIA, United States
Website
inhealth.com/
Phone
8055765317
PRRC contact
Michael Kilday(public in EUDAMED)

FDA recalls4

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

  • 2026

    • 17 Jun 2026 Z-2909-2026 Class II Ongoing Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. Submission number: K932120
    • 17 Jun 2026 Z-2910-2026 Class II Ongoing Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. Submission number: K932120

  • 2022

    • 21 Feb 2022 Z-1016-2022 Class II Terminated Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemiavia FDA establishment Freudenberg Medical, SRL Distribution: US distribution: GA, OH Foreign distribution: Netherlands Submission number: K190628
    • 21 Feb 2022 Z-1017-2022 Class II Terminated Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemiavia FDA establishment Freudenberg Medical, SRL Distribution: US distribution: GA, OH Foreign distribution: Netherlands Submission number: K190628

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • Freudenberg Medical, LLC CARPINTERIA, CA · US FEI 2025182
  • Freudenberg Medical, SRL La Garita Alajuela · CR FEI 3011241266

Frequently asked questions

How many devices does Freudenberg Medical LLC have in the registry?

The registry currently lists 354 devices for Freudenberg Medical LLC. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for Freudenberg Medical LLC?

FDA recall records list 4 recalls initiated by Freudenberg Medical LLC, the most recent initiated on 17 Jun 2026. 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.

Which FDA establishments are linked to Freudenberg Medical LLC?

2 FDA establishments are linked to Freudenberg Medical LLC in the registry; they are listed on the company page.

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