510(k) Report

FDA applicant

Molnlycke/Scott Health Care

Fort Worth, TX1 decision1996–19960 recalls

FDA records 1 decision for Molnlycke/Scott Health Care (Fort Worth, TX) in 1996: 1 510(k) clearance. All are in product code NAD (Dressing, Wound, Occlusive). 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Molnlycke/Scott Health Care’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Molnlycke/Scott Health Care since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Molnlycke/Scott Health Care by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Molnlycke/Scott Health Care’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NADDressing, Wound, Occlusive1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K955863Alldress Multi Layered Wound DressingMolnlycke/Scott Health Care · 1996

The one decision as Molnlycke/Scott Health Care →

Other applicant names beginning “Molnlycke/Scott”

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

Molnlycke Health Care Us, LLC 27Molnlycke Health Care, Inc. 19Molnlycke A/S Hospital Products 3Molnlycke Health Care USA 1Molnlycke Clinical Products AB 1