FDA applicant

Gainor Medical Europe, Ltd.

Mcdonough, GA13 decisions1990–19940 recalls

FDA records 13 decisions for Gainor Medical Europe, Ltd. (Mcdonough, GA) from 1990 to 1994: 13 510(k) clearances. Most are in product codes FMK (Single Use Only Blood Lancet With An Integral…) and FPA (Set, Administration, Intravascular). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Gainor Medical Europe, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gainor Medical Europe, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gainor Medical Europe, 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 “Gainor”

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

Gainor Medical 11 Gainor Medical U.S.A., Inc. 2

Gainor Medical Europe, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Gainor”