510(k) Report

FDA applicant

Medscand AB

Malmo, SE2 decisions1993–19980 recalls

FDA records 2 decisions for Medscand AB (Malmo, SE) from 1993 to 1998: 2 510(k) clearances. Most are in product codes HHT (Spatula, Cervical, Cytological) and HIB (Speculum, Vaginal, Nonmetal). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Medscand AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medscand AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medscand 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?

  • HHTSpatula, Cervical, Cytological1decision
  • HIBSpeculum, Vaginal, Nonmetal1decision

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.

  • K984211Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303Medscand AB · 19982cite it

What has FDA decided for it lately?

  • K984211Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303Medscand AB · 1998
  • K911432Accellon Cervical BiosamplerMedscand AB · 1993

All 2 as Medscand AB →

Other applicant names beginning “Medscand”

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

Medscand (Usa), Inc. 1