FDA applicant

Actherm, Inc.

Hsinchu, TW8 decisions2001–20100 recalls

FDA records 8 decisions for Actherm, Inc. (Hsinchu, TW) from 2001 to 2010: 8 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 10 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, general hospital panel, where it files most

How often FDA has decided Actherm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 2 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Actherm, Inc.

Which product codes does it file in?

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?