FDA applicant

Tetra Corp.

Englewood, CO5 decisions1993–19960 recalls

FDA records 5 decisions for Tetra Corp. (Englewood, CO) from 1993 to 1996: 5 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Tetra Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Tetra”

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

Tetra Group U.S.A., Inc. 1

Tetra Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Tetra”