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Dukal LLC

Also registered as Dukal Corp., Dukal Corporation

United StatesFDA applicant, unverified FDA FEI 1000137528

Dukal LLC is a medical device manufacturer, with 912 devices listed in FDA GUDID and FDA 510(k) (FDA Class I, Class II and Unclassified) and 1 FDA recall as of 13 Nov 2026.

Devices
912
Registrations
FDA
FDA recalls
1

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 892
  • FDA 510(k) 20

A device listed in two registries counts in both.

Device classes
  • FDA Class I 766
  • FDA Class II 101
  • FDA Unclassified 45
FDA recalls
Identifiers
  • FDA FEI 1000137528
  • DUNS 791014871

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Dukal LLC makes

Dukal LLC produces non-antimicrobial medical dressings, including adhesive strips, woven and non-woven gauze pads, and radiopaque surgical sponges. Their portfolio also covers sterilization wraps, skin adhesive tapes (non-silicone), reusable instrument trays, and single-use isolation gowns. Woven gauze rolls and sheets are available for wound care applications.

The company’s products are regulated under FDA classifications, including Class I, Class II, and unclassified (U) devices. Devices are listed via 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue912

Newest first, rows 1-50 of 912

Search and filter all 912 devices
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  • Dukal 1087759

    Listed Registry: GUDID Class:I

  • Dukal 1087760

    Listed Registry: GUDID Class:I

  • Dukal 11130

    Listed Registry: GUDID Class:I

  • Dukal 11127

    Listed Registry: GUDID Class:I

  • Dukal 9860

    Listed Registry: GUDID Class:I

  • Dukal 5500

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

  • Dukal 9861

    Listed Registry: GUDID Class:I

  • Dukal 5501

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

  • Dukal 5502

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

  • Rencura RCSA33

    Listed Registry: GUDID Class:I

  • Rencura RCSA44

    Listed Registry: GUDID Class:I

  • Rencura RCSA68

    Listed Registry: GUDID Class:I

  • Rencura RCSA48

    Listed Registry: GUDID Class:I

  • Dukal 5503

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

  • Rencura RCSB44

    Listed Registry: GUDID Class:I

  • Rencura RCSB33

    Listed Registry: GUDID Class:I

  • Rencura RCSB55

    Listed Registry: GUDID Class:I

  • Rencura RCSB66

    Listed Registry: GUDID Class:I

  • Rencura RCSB77

    Listed Registry: GUDID Class:I

  • Rencura RCSB7S

    Listed Registry: GUDID Class:I

  • Rencura RCCL22

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

  • Dukal Upst-050

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

  • Rencura RCCL44

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

  • Dukal Upst-075

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

  • Dukal Upst-100

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

  • Dukal 5530

    Listed Registry: GUDID Class:I

  • Rencura RCCL11

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

  • Dukal 8504

    Listed Registry: GUDID Class:I

  • Dukal 8512

    Listed Registry: GUDID Class:I

  • Dukal A1515

    Listed Registry: GUDID Class:I

  • Dukal Crepe Paper Sterilization Wrap Ref K252823

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

  • Dukal 27202

    Listed Registry: GUDID Class:I

  • Dukal 27613

    Listed Registry: GUDID Class:I

  • Dukal 6125

    Listed Registry: GUDID Class:I

  • Tech-Med 2050

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

  • Tech-Med 4266

    Listed Registry: GUDID Class:I

  • Unipack UGC-6605-M

    Listed Registry: GUDID Class:I

  • Dukal 879

    Listed Registry: GUDID Class:I

  • Unipack UGC-6601-XL

    Listed Registry: GUDID Class:I

  • Dukal 406

    Listed Registry: GUDID Class:I

  • Dukal 4122

    Listed Registry: GUDID Class:I

  • Dukal UPP-29

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

  • Dukal 7007101

    Listed Registry: GUDID Class:I

  • Dukal 16700

    Listed Registry: GUDID Class:I

  • American White Cross 1275033

    Listed Registry: GUDID Class:I

  • Dukal 5157

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

  • Dukal 4162

    Listed Registry: GUDID Class:I

  • Unipack UGC-6613-L

    Listed Registry: GUDID Class:I

  • American White Cross 1086737

    Listed Registry: GUDID Class:I

  • Dukal 27612

    Withdrawn Registry: GUDID Class:I

Rows 1-50 of 912

Showing 1-50 of 912

Company details

FDA FEI number
1000137528
DUNS number
791014871
Address
2 Fleetwood Ct., Ronkonkoma, NY, 11779
Phone
+1(631)656-3800

FDA recalls1

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

FDA recall records list 1 recall initiated by Dukal LLC, initiated on 2017-06-01. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

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

  • 2017

    • 1 Jun 2017 Z-0233-2018 Class II Terminated Intact carton revealed presence of shredded burn sheets Distribution: Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX &…
      Full distribution text Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada

Frequently asked questions

How many devices does Dukal LLC have in the registry?

The registry currently lists 912 devices for Dukal LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dukal LLC's devices?

Among its 50 most recently registered devices, Dukal LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Dukal LLC's devices fall under?

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

Are there FDA recall records for Dukal LLC?

FDA recall records list 1 recall initiated by Dukal LLC, the most recent initiated on 1 Jun 2017. 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 Dukal LLC in the registry?

The most recently registered devices listed for Dukal LLC include Dukal 1087759, Dukal 1087760, Dukal 11130 and Dukal 11127.

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