FDA applicant

Island Biosurgical, Inc.

Mercer Island, WA4 decisions1996–20000 recalls

FDA records 4 decisions for Island Biosurgical, Inc. (Mercer Island, WA) from 1996 to 2000: 4 510(k) clearances. Most are in product codes OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…) and KOD (Catheter, Urological). No recall is linked to its devices.

FDA’s records also spell it “Island Biosurgical, LLC”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Island Biosurgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Island Biosurgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Island”

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

Island Medical 2 Island Dental Lab, Inc Dba Emerald Dental 1 Island Critical Care Corp. 1 Island Dressing, LLC 1

Island Biosurgical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Island”