FDA applicant

Isomedix Operations, Inc.

North Attleboro, MA2 decisions1995–19970 recalls

FDA records 2 decisions for Isomedix Operations, Inc. (North Attleboro, MA) from 1995 to 1997: 2 510(k) clearances. Most are in product codes FYD (Apparatus, Exhaust, Surgical) and DQY (Catheter, Percutaneous). 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, general and plastic surgery panel, where it files most

How often FDA has decided Isomedix Operations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Isomedix Operations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Isomedix Operations, Inc.

Which product codes does it file in?

What has FDA decided for it lately?