510(k) Report

FDA applicant

Walgen Medical Innoventions

Mchenry, IL3 decisions1981–19860 recalls

FDA records 3 decisions for Walgen Medical Innoventions (Mchenry, IL) from 1981 to 1986: 3 510(k) clearances. Most are in product codes FWZ (Operating Room Accessories Table Tray) and JDY (Evacuator, Vapor, Cement Monomer). 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 Walgen Medical Innoventions’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Walgen Medical Innoventions since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FWZOperating Room Accessories Table Tray1decision
  • JDYEvacuator, Vapor, Cement Monomer1decision

What has FDA decided for it lately?

  • K861292CastalertWalgen Medical Innoventions · 1986
  • K810433Lower Extremity Support System-LessWalgen Medical Innoventions · 1981
  • K810542Cement Fume Evacuator Tank & FilterWalgen Medical Innoventions · 1981

All 3 as Walgen Medical Innoventions →