510(k) Report

FDA applicant

Valeant Pharmaceuticals

Rochester, NY1 decision2018–20180 recalls

FDA records 1 decision for Valeant Pharmaceuticals (Rochester, NY) in 2018: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 3 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 Valeant Pharmaceuticals’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Valeant Pharmaceuticals by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K173549BiafineValeant Pharmaceuticals · 20183cite it

What has FDA decided for it lately?

  • K173549BiafineValeant Pharmaceuticals · 2018

The one decision as Valeant Pharmaceuticals →