510(k) Report

FDA applicant

Medi-Stim A/S

Brooklyn Park, MN2 decisions1999–20041 recall

FDA records 2 decisions for Medi-Stim A/S (Brooklyn Park, MN) from 1999 to 2004: 2 510(k) clearances. Most are in product codes DPW (Flowmeter, Blood, Cardiovascular) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 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 Medi-Stim A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medi-Stim A/S since 2007.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medi-Stim A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Medi-Stim”

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