510(k) Report

FDA applicant

Transamerica Biomedical, Inc.

South Hadley, MA1 decision1995–19950 recalls

FDA records 1 decision for Transamerica Biomedical, Inc. (South Hadley, MA) in 1995: 1 510(k) clearance. All are in product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Transamerica Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Transamerica Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Transamerica”

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