510(k) Report

FDA applicant

Amplaid USA, Inc.

Mchenry, IL8 decisions1978–19860 recalls

FDA records 8 decisions for Amplaid USA, Inc. (Mchenry, IL) from 1978 to 1986: 8 510(k) clearances. Most are in product codes GWJ (Stimulator, Auditory, Evoked Response) and EWO (Audiometer). 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 Amplaid USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amplaid USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Amplaid USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Amplaid”

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