FDA applicant

Transoma Medical

Arden Hills, MN2 decisions2007–20090 recalls

FDA records 2 decisions for Transoma Medical (Arden Hills, MN) from 2007 to 2009: 2 510(k) clearances. All are in product code MXC (Recorder, Event, Implantable Cardiac, (Without…). Its devices cite 2 predicates, 0 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2009

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Transoma”

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

Transoma 1

Transoma Medical

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?

Other applicant names beginning “Transoma”