FDA applicant

Microware Precision Co., Ltd.

Taichung City, TW8 decisions2008–20240 recalls

FDA records 8 decisions for Microware Precision Co., Ltd. (Taichung City, TW) from 2008 to 2024: 8 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 224 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 6 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2024

2008high 2 (2022) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

Planning a device like Microware Precision 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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Other applicant names beginning “Microware”

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

Microware, Inc. 1

Microware Precision Co., Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Microware”