FDA applicant

Sime Health, Ltd.

Seattle, WA11 decisions1991–19950 recalls

FDA records 11 decisions for Sime Health, Ltd. (Seattle, WA) from 1991 to 1995: 11 510(k) clearances. Most are in product codes HIS (Condom) and LYY (Latex Patient Examination Glove). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Sime Health, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sime Health, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sime Health, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sime”

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

Sime Darby USA 2

Sime Health, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sime”