510(k) Report

FDA applicant

Arbo Medical, Inc.

Stratford, CT15 decisions1989–19950 recalls

FDA records 15 decisions for Arbo Medical, Inc. (Stratford, CT) from 1989 to 1995: 15 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and DSA (Cable, Transducer And Electrode, Patient…). 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 Arbo Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arbo Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Arbo Medical, 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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