FDA applicant

Gallini U.S., LLC

Richmond, VA10 decisions1997–19990 recalls

FDA records 10 decisions for Gallini U.S., LLC (Richmond, VA) from 1997 to 1999: 10 510(k) clearances. All are in product code KNW (Instrument, Biopsy). 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 Gallini U.S., LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gallini U.S., LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gallini U.S., LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Gallini”

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

Gallini Intl., Inc. 7 Gallini S.R.L. 1 Gallini Medical Devices, Srl 1

Gallini U.S., LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gallini”