FDA applicant
Medi-Stim A/S
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
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
Class I Class II/III not classified
Planning a device like Medi-Stim A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Medi-Stim”
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