510(k) Report

FDA applicant

Stiefel Laboratories, Inc.

Oak Hill, NY1 decision2005–20050 recalls

FDA records 1 decision for Stiefel Laboratories, Inc. (Oak Hill, NY) in 2005: 1 510(k) clearance. All are in product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Stiefel Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stiefel Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stiefel Laboratories, 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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 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.

  • K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 200517cite it

What has FDA decided for it lately?

  • K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005

The one decision as Stiefel Laboratories, Inc. →

Other applicant names beginning “Stiefel”

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

Stiefel Research Institute, Inc. 6