FDA applicant

Tomtec

Mchenry, IL2 decisions1977–19810 recalls

FDA records 2 decisions for Tomtec (Mchenry, IL) from 1977 to 1981: 2 510(k) clearances. All are in product code KPA (Slide Stainer, Automated). 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, pathology panel, where it files most

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

FDA decisions per year

No FDA decision for Tomtec since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Tomtec”

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

Tomtec Imaging Systems GmbH 23 Tomtec Tomographic Technologies GmbH 1

Tomtec

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Tomtec”