510(k) Report

FDA applicant

Andromeda Research, Inc.

Oyster Bay, NY1 decision1986–19860 recalls

FDA records 1 decision for Andromeda Research, Inc. (Oyster Bay, NY) in 1986: 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 Andromeda Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Andromeda Research, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Andromeda Research, 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 “Andromeda”

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