510(k) Report

FDA applicant

Mochida Pharmaceutical Co., Ltd.

Bridgeport, CT4 decisions1984–20240 recalls

FDA records 4 decisions for Mochida Pharmaceutical Co., Ltd. (Bridgeport, CT) from 1984 to 2024: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and JXI (Cuff, Nerve). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Mochida Pharmaceutical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mochida Pharmaceutical Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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