510(k) Report

FDA applicant

Marda Medical, Inc.

Jensen Beach, FL1 decision2005–20050 recalls

FDA records 1 decision for Marda Medical, Inc. (Jensen Beach, FL) in 2005: 1 510(k) clearance. All are in product code IRQ (Unit, Heating, Powered). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Marda Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Marda Medical, 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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Which product codes does it file in?

  • IRQUnit, Heating, Powered1decision

What has FDA decided for it lately?

  • K050524EZ-IV Medical Pad Warming Unit, Model 1000Marda Medical, Inc. · 2005

The one decision as Marda Medical, Inc. →