FDA applicant

Swemed Lab International AB

Billdal, SE4 decisions1999–20060 recalls

FDA records 4 decisions for Swemed Lab International AB (Billdal, SE) from 1999 to 2006: 4 510(k) clearances. Most are in product codes MQH (Microtools, Assisted Reproduction (Pipettes)) and MQF (Catheter, Assisted Reproduction). Its devices cite 6 predicates, 0 of them its own earlier devices. 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 Swemed Lab International AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Swemed Lab International AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Swemed Lab International AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Swemed Lab International AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Swemed”

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

Swemed Laboratories, Inc. 2 Swemed Lab Intl. 1

Swemed Lab International AB

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Swemed”