FDA applicant

Armstrong Healthcare Limited

High Wycombe, GB3 decisions1997–20050 recalls

FDA records 3 decisions for Armstrong Healthcare Limited (High Wycombe, GB) from 1997 to 2005: 3 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HAW (Neurological Stereotaxic Instrument). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Armstrong Healthcare , Ltd.”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Armstrong Healthcare Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Armstrong Healthcare Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Armstrong”

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

Armstrong Ind., Inc. 5 Armstrong Industries, Inc. 3 Armstrong Medical, Ltd. 1 Armstrong Industries, Inc. Dha Mediquip Int. Dha S 1

Armstrong Healthcare Limited

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Armstrong”