FDA applicant

Hi-Tronics Designs, Inc.

Budd Lake, NJ2 decisions1995–19980 recalls

FDA records 2 decisions for Hi-Tronics Designs, Inc. (Budd Lake, NJ) from 1995 to 1998: 2 510(k) clearances. All are in product code DXH (Transmitters And Receivers…). 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 Hi-Tronics Designs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hi-Tronics Designs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hi-Tronics Designs, Inc.

Which product codes does it file in?

What has FDA decided for it lately?