510(k) Report

FDA applicant

Paragon Medical and Scientific, Inc.

Saint Paul, MN1 decision1986–19860 recalls

FDA records 1 decision for Paragon Medical and Scientific, Inc. (Saint Paul, MN) in 1986: 1 510(k) clearance. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Paragon Medical and Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Paragon Medical and Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Paragon Medical and Scientific, 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 “Paragon”

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