510(k) Report

FDA applicant

Tms International BV

Evergreen, CO2 decisions2006–20070 recalls

FDA records 2 decisions for Tms International BV (Evergreen, CO) from 2006 to 2007: 2 510(k) clearances. All are in product code GWL (Amplifier, Physiological Signal). 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, neurology panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GWLAmplifier, Physiological Signal2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060374Refa, Physiological AmplifierTms International BV · 20061cites it

What has FDA decided for it lately?

  • K063599Porti 7 Physiological AmplifierTms International BV · 2007
  • K060374Refa, Physiological AmplifierTms International BV · 2006

All 2 as Tms International BV →