510(k) Report

FDA applicant

Werner Eidam Medizin-Technologie GmbH

Washington, DC1 decision1997–19970 recalls

FDA records 1 decision for Werner Eidam Medizin-Technologie GmbH (Washington, DC) in 1997: 1 510(k) clearance. All are in product code LHQ (System, Telethermographic (Adjunctive Use)). 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 Werner Eidam Medizin-Technologie GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Werner Eidam Medizin-Technologie GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Werner Eidam Medizin-Technologie GmbH 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?

  • LHQSystem, Telethermographic (Adjunctive Use)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K971956CRT2000 Thermographic SystemWerner Eidam Medizin-Technologie GmbH · 19972cite it

What has FDA decided for it lately?

  • K971956CRT2000 Thermographic SystemWerner Eidam Medizin-Technologie GmbH · 1997

The one decision as Werner Eidam Medizin-Technologie GmbH →

Other applicant names beginning “Werner”

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

Werner Schott Elektrogerate 1