510(k) Report

FDA applicant

Taiwan Biomaterial Co., Ltd.

Zhubei, TW2 decisions2018–20190 recalls

FDA records 2 decisions for Taiwan Biomaterial Co., Ltd. (Zhubei, TW) from 2018 to 2019: 2 510(k) clearances. All are in product code JCX (Apparatus, Suction, Ward Use, Portable…). Its devices cite 2 predicates, 1 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 Taiwan Biomaterial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Taiwan Biomaterial Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180115TWBM PumpTaiwan Biomaterial Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K190105ZOOM Aspiration PumpTaiwan Biomaterial Co., Ltd. · 2019
  • K180115TWBM PumpTaiwan Biomaterial Co., Ltd. · 2018

All 2 as Taiwan Biomaterial Co., Ltd. →