510(k) Report

FDA applicant

Neomedic International S.L.

Minneapolis, MN3 decisions2011–20120 recalls

FDA records 3 decisions for Neomedic International S.L. (Minneapolis, MN) from 2011 to 2012: 3 510(k) clearances. Most are in product codes OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…) and PBQ (Fixation, Non-Absorbable Or Absorbable, For…). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Neomedic International”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Neomedic International S.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 22012: 1
2011high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Neomedic International S.L. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…1decision
  • PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use1decision
  • OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally…1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K120831AnchorsureNeomedic International S.L. · 20122cite it

What has FDA decided for it lately?

  • K120831AnchorsureNeomedic International S.L. · 2012
  • K103022KIMNeomedic International S.L. · 2011
  • K102815Surelift Prolapse SystemNeomedic International · 2011

All 2 as Neomedic International S.L. →The one decision as Neomedic International →