FDA applicant

Shanghai Mediworks Precision Instruments Co., Ltd.

Shanghai, CN3 decisions2010–20160 recalls

FDA records 3 decisions for Shanghai Mediworks Precision Instruments Co., Ltd. (Shanghai, CN) from 2010 to 2016: 3 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and HKY (Tonometer, Manual). 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, ophthalmic panel, where it files most

How often FDA has decided Shanghai Mediworks Precision Instruments Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2010high 2 (2016) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Shanghai Mediworks Precision Instruments Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Shanghai Mediworks Precision Instruments Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?