510(k) Report

FDA applicant

Emerson & Co. Srl

Genoa, IT3 decisions1998–20210 recalls

FDA records 3 decisions for Emerson & Co. Srl (Genoa, IT) from 1998 to 2021: 3 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZC (Medical Glove, Specialty). 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 and plastic surgery panel, where it files most

How often FDA has decided Emerson & Co. Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12021: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Emerson & Co. Srl by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Emerson”

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