510(k) Report

FDA applicant

Molnlycke Clinical Products AB

Chicago, IL1 decision1992–19920 recalls

FDA records 1 decision for Molnlycke Clinical Products AB (Chicago, IL) in 1992: 1 510(k) clearance. All are in product code NAB (Gauze / Sponge,Nonresorbable For External Use). 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 Clinical Products AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Molnlycke Clinical Products AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Molnlycke Clinical Products AB 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?

  • NABGauze / Sponge,Nonresorbable For External Use1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K914604Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 19921cites it

What has FDA decided for it lately?

  • K914604Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992

The one decision as Molnlycke Clinical Products AB →

Other applicant names beginning “Molnlycke”

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/Scott Health Care 1Molnlycke Health Care USA 1