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Data / Medical devices / United States / Medline Industries, LP

Medline Industries, LP: FDA-registered device maker in Norristown, PA, United States, 1 510(k) clearance

Medline Industries, LP is registered with the FDA (registration 3007128716) in Norristown, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 26, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3007128716
Address
2495 General Armistead Avenue Suite B, Norristown, PA, United States, 19403
Owner or operator
Medline Industries, LP (1417592)
Roles
Manufacturer
First device listed
November 14, 2024
Registered through
2027
Brand names listed
Plurogel Burn and Wound Dressing

Devices it lists

DeviceProduct codeClassRoleSource
Dressing, Wound, DrugFROUManufactureraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 26, 2024K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)FROSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov

Compare with other makers

Updated March 26, 2024. 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.