510(k) Report

FDA applicant

Amferia AB

Molndal, SE1 decision2026–20260 recalls

FDA records 1 decision for Amferia AB (Molndal, SE) in 2026: 1 De Novo grant. All are in product code SHA (Solid Wound Dressing With Permanently Bound…). 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 Amferia AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Which product codes does it file in?

  • SHASolid Wound Dressing With Permanently Bound Antimicrobial Agent1decision

What has FDA decided for it lately?

  • DEN250006Amferia Wound DressingAmferia AB · 2026

The one decision as Amferia AB →