510(k) Report

FDA applicant

Island Critical Care Corp.

Stratford, P.E.I., CA1 decision2001–20010 recalls

FDA records 1 decision for Island Critical Care Corp. (Stratford, P.E.I., CA) in 2001: 1 510(k) clearance. All are in product code DQA (Oximeter). No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Island Critical Care Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Island Critical Care Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Island”

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