510(k) Report

FDA applicant

S & W Medico Teknik A/S

Albertslund, DK3 decisions1994–19970 recalls

FDA records 3 decisions for S & W Medico Teknik A/S (Albertslund, DK) from 1994 to 1997: 3 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DXK (Echocardiograph). 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, cardiovascular panel, where it files most

How often FDA has decided S & W Medico Teknik A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for S & W Medico Teknik A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — S & W Medico Teknik A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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