FDA applicant

Abbott Ireland

Longford, IE2 decisions2025–20250 recalls

FDA records 2 decisions for Abbott Ireland (Longford, IE) in 2025: 2 510(k) clearances. Most are in product codes CFR (Hexokinase, Glucose) and CJY (Azo Dye, Calcium). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, clinical chemistry panel, where it files most

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

FDA decisions per year

2in 2025

2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Abbott Ireland by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Abbott Ireland’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 “Abbott”

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

Abbott Laboratories 920 Abbott Medical 92 Abbott Vascular 64 Abbott Diabetes Care, Inc. 42 Abbott Molecular, Inc. 33 Abbott Diagnostics 28 Abbott Point of Care, Inc. 22 Abbott Medical Optics, Inc. 16 Abbott Mfg., Inc. 14 Abbott 14 Abbott Spine, Inc. 13 Abbott Diagnostics Scarborough, Inc. 8

Abbott Ireland

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Abbott”