FDA applicant

Gainor Medical

Unnamed device11 decisions1984–19870 recalls

FDA records 11 decisions for Gainor Medical (Unnamed device) from 1984 to 1987: 11 510(k) clearances. Most are in product codes KGX (Tape And Bandage, Adhesive) and FMK (Single Use Only Blood Lancet With An Integral…). 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 Gainor Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gainor Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gainor Medical 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 Europe, Ltd. 13 Gainor Medical U.S.A., Inc. 2

Gainor Medical

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gainor”