510(k) Report

FDA applicant

Nortrade Medical, Inc.

Sandy, UT3 decisions1999–19991 recall

FDA records 3 decisions for Nortrade Medical, Inc. (Sandy, UT) in 1999: 3 510(k) clearances. All are in product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). 1 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 Nortrade Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nortrade Medical, Inc. 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?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic3decisions

What has FDA decided for it lately?

  • K990179Burnfree 1/8 OZ. Sterile Pain Relieving Gel, Model SDNortrade Medical, Inc. · 19991 recall
  • K990178Burnfree Pain Relieving Gel, Model 4BNortrade Medical, Inc. · 1999
  • K990180Burnfree (4X4, 8X8, 16X24) Sterile Burn & Wound DressingNortrade Medical, Inc. · 1999

All 3 as Nortrade Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K913569Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before…Feb 1, 2006