510(k) Report

FDA applicant

Merocel Corp.

Mystic, CT10 decisions1992–19950 recalls

FDA records 10 decisions for Merocel Corp. (Mystic, CT) from 1992 to 1995: 10 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and LYA (Splint, Intranasal Septal). 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, ear, nose and throat panel, where it files most

How often FDA has decided Merocel Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Merocel Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Merocel Corp.’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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