510(k) Report

FDA applicant

Hanin Medical Services Co., Ltd.

Monroe, CT1 decision2014–20140 recalls

FDA records 1 decision for Hanin Medical Services Co., Ltd. (Monroe, CT) in 2014: 1 510(k) clearance. All are in product code MHX (Monitor, Physiological, Patient (With…). 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, cardiovascular panel, where it files most

How often FDA has decided Hanin Medical Services Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Hanin Medical Services Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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