Data / Medical devices / United States / Dukal LLC

Dukal LLC: FDA-registered device maker in Ronkonkoma, NY, United States, 22 510(k) clearances

Dukal LLC is registered with the FDA (registration 2435946) in Ronkonkoma, NY, United States. It lists 89 device types. The FDA files 22 510(k) clearances under its listings, the newest dated October 10, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number

2435946

FEI number

1000137528

Address

2 Fleetwood Ct., Ronkonkoma, NY, United States, 11779

Owner or operator

DUKAL LLC (9005925)

Roles

Complaint file establishment, Specification developer

First device listed

May 11, 1995

Registered through

2027

Brand names listed

Bone Dust Collector(Private Label Brand), DUKAL Cotton Tip Applicator, DUKAL ELASTIC BANDAGE LATEX, DUKAL EYE PAD, DUKAL GAUZE PAD, DUKAL ISOLATION GOWN, DUKAL Instant Hot Packs, DUKAL Protective Coverall with Hood and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Compare with other makers

• All makers of Indicator, Physical/Chemical Sterilization Process
• All makers of Percussor
• All makers of Dispenser, Solid Medication
• All makers of Bandage, Cast
• All makers of Container, Specimen, Non-Sterile
• All makers of Pad, Alcohol, Device Disinfectant

Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.