FDA applicant

Scandinavian Medical JW AB

Washington, DC1 decision1995–19950 recalls

FDA records 1 decision for Scandinavian Medical JW AB (Washington, DC) in 1995: 1 510(k) clearance. All are in product code KCY (Tourniquet, Pneumatic). 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 Scandinavian Medical JW AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scandinavian Medical JW AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Scandinavian Medical JW 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 “Scandinavian”

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

Scandinavian Health Limited 4 Scandinavian Formulas, Inc. 1

Scandinavian Medical JW AB

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Scandinavian”