510(k) Report

FDA applicant

Medix Pharmaceuticals Americas, Inc.

Washington, DC1 decision1997–19970 recalls

FDA records 1 decision for Medix Pharmaceuticals Americas, Inc. (Washington, DC) in 1997: 1 510(k) clearance. All are in product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). 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 Medix Pharmaceuticals Americas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medix Pharmaceuticals Americas, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medix Pharmaceuticals Americas, 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 Biologic1decision

Who builds on its devices?

Later devices cite its devices 13 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964240Biafine Wound Dressing EmulsionMedix Pharmaceuticals Americas, Inc. · 199713cite it

What has FDA decided for it lately?

  • K964240Biafine Wound Dressing EmulsionMedix Pharmaceuticals Americas, Inc. · 1997

The one decision as Medix Pharmaceuticals Americas, Inc. →

Other applicant names beginning “Medix”

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

Medix Biotech, Inc. 39Medix Medical Electronics (U.S.A.), Inc. 14Medix I.C.S.A. 6Medix Corp. 6Medix Biochemica 1Medix of Florida, Inc. 1