510(k) Report

FDA applicant

Q-Med AB

Uppsala4 decisions2003–20160 recalls

FDA records 4 decisions for Q-Med AB (Uppsala) from 2003 to 2016: 4 original PMA approvals. All are in product code LMH (Implant, Dermal, For Aesthetic 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 Q-Med AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Q-Med 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?

  • LMHImplant, Dermal, For Aesthetic Use4decisions

What has FDA decided for it lately?

  • P140029Restylane Refyne, Restylane DefyneQ-Med AB · 2016
  • P040024Restylane Injectable GelQ-Med AB · 2005
  • P030050Sculptra and Sculptra AestheticQ-Med AB · 2004
  • P020023Restylane Injectable GelQ-Med AB · 2003

All 4 as Q-Med AB →