FDA applicant

Medical Bio Care Sweden AB

Woodland, CA10 decisions2000–20020 recalls

FDA records 10 decisions for Medical Bio Care Sweden AB (Woodland, CA) from 2000 to 2002: 10 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 predicates, 3 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, general and plastic surgery panel, where it files most

How often FDA has decided Medical Bio Care Sweden AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Bio Care Sweden AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Bio Care Sweden AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Medical Bio Care Sweden 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?