510(k) Report

FDA applicant

Novamed Products, Inc.

Quebec, Canada H4m2p1, CA2 decisions1982–19860 recalls

FDA records 2 decisions for Novamed Products, Inc. (Quebec, Canada H4m2p1, CA) from 1982 to 1986: 2 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and BWF (Spirometer, Therapeutic (Incentive)). 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 Novamed Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novamed Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Novamed Products, 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 “Novamed”

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