FDA applicant

Harvard Medical Devices, Ltd.

Tsimshatsui, Kowloon, HK5 decisions2008–20100 recalls

FDA records 5 decisions for Harvard Medical Devices, Ltd. (Tsimshatsui, Kowloon, HK) from 2008 to 2010: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). 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 Harvard Medical Devices, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2008high 2 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Harvard Medical Devices, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Harvard Medical Devices, 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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Other applicant names beginning “Harvard”

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

Harvard Apparatus, Inc. 9 Harvard Laboratories 8 Harvard Clinical Technology 2

Harvard Medical Devices, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Harvard”