510(k) Report

FDA applicant

Andromed, Inc.

Saint Laurent, Quebec, CA5 decisions2000–20050 recalls

FDA records 5 decisions for Andromed, Inc. (Saint Laurent, Quebec, CA) from 2000 to 2005: 5 510(k) clearances. Most are in product codes DQD (Stethoscope, Electronic) and BZQ (Monitor, Breathing Frequency). 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 Andromed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Andromed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Andromed, 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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