510(k) Report

FDA applicant

Island Dressing, LLC

Amherst, NY1 decision2001–20010 recalls

FDA records 1 decision for Island Dressing, LLC (Amherst, NY) in 2001: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Island Dressing, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Island Dressing, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Island Dressing, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

What has FDA decided for it lately?

  • K010951Island Wound Dressing with MicrobanIsland Dressing, LLC · 2001

The one decision as Island Dressing, LLC →

Other applicant names beginning “Island”

FDA records each applicant name separately; these may or may not be the same firm.

Island Biosurgical, Inc. 4Island Medical 2Island Dental Lab, Inc Dba Emerald Dental 1Island Critical Care Corp. 1