510(k) Report

FDA applicant

Imed Ireland, Ltd.

Walker, MI1 decision1982–19820 recalls

FDA records 1 decision for Imed Ireland, Ltd. (Walker, MI) in 1982: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 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, general hospital panel, where it files most

How often FDA has decided Imed Ireland, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Imed Ireland, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Imed”

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