510(k) Report

FDA applicant

Mutoh America Co., Ltd.

Deer Field, IL1 decision2001–20014 recalls

FDA records 1 decision for Mutoh America Co., Ltd. (Deer Field, IL) in 2001: 1 510(k) clearance. All are in product code LFL (Instrument, Ultrasonic Surgical). 4 recalls are linked to its devices.

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

How often FDA has decided Mutoh America Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mutoh America Co., Ltd. since 2007.

Recalls per year

1in 2014

2013: 32014: 1
2007high 3 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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