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Acell, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000024874 FEI 3005920706

Acell, Inc. is a medical device manufacturer based in the United States, with 236 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II, Unclassified and Class I) and 3 FDA recalls as of 12 Nov 2026.

Devices
236
Registrations
EUDAMEDFDA
FDA recalls
3

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 216
  • EUDAMED 20
  • FDA 510(k) 20

A device listed in two registries counts in both.

Device classes
  • FDA Class II 98
  • FDA Unclassified 97
  • FDA Class I 41
FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000024874
  • FDA FEI 3005920706
  • DUNS 137258252

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

Catalogue236

Newest first, rows 1-50 of 236

Search and filter all 236 devices
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Rows 1-50 of 236

Showing 1-50 of 236

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000024874
FDA FEI number
3005920706
DUNS number
137258252
EUDAMED status
Active
EUDAMED registered name
Acell Inc.
EUDAMED abbreviated name
Integra - Columbia
Registered address
6640, Eli Whitney Drive, 21046, Columbia, MD, United States
Phone
+1(800)826-2926
PRRC contact
Stacie Wright(public in EUDAMED)

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

1 initiated before 2017

  • 2019

    • 14 Feb 2019 Z-1032-2019 Class II Terminated The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. Distribution: US nationwide distribution in the state of CA. Submission number: K170763
    • 14 Feb 2019 Z-1033-2019 Class II Terminated The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. Distribution: US nationwide distribution in the state of CA. Submission number: K170763

  • 2011

    • 7 Jul 2011 Z-2855-2011 Unclassified (pre-2012) Terminated Surgical mesh for implantation may have elevated endotoxin levels. Distribution: Nationwide (USA) Distribution including the states of CA, CT, FL, ID, IL, MD, MI, MS, NC, NJ, NV, NY, OH, OR, PA, TX and…
      Full distribution text Nationwide (USA) Distribution including the states of CA, CT, FL, ID, IL, MD, MI, MS, NC, NJ, NV, NY, OH, OR, PA, TX and VA

Frequently asked questions

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

The registry currently lists 236 devices for ACELL, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ACELL, INC.'s devices?

Among its 50 most recently registered devices, ACELL, INC. has devices listed in EUDAMED (3 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

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

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

Are there FDA recall records for ACELL, INC.?

FDA recall records list 3 recalls initiated by ACELL, INC., the most recent initiated on 14 Feb 2019. 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 ACELL, INC. in the registry?

The most recently registered devices listed for ACELL, INC. include MediHoney® 31515, MediHoney® 31815, MediHoney® 31535 and MediHoney® 31505.

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