510(k) Report

FDA applicant

Panamedix, Inc.

Costa Mesa, CA6 decisions1986–19880 recalls

FDA records 6 decisions for Panamedix, Inc. (Costa Mesa, CA) from 1986 to 1988: 6 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Panamedix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Panamedix, 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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