510(k) Report

FDA applicant

Medsafe Asa

Oslo, NO1 decision2006–20060 recalls

FDA records 1 decision for Medsafe Asa (Oslo, NO) in 2006: 1 510(k) clearance. All are in product code MEG (Syringe, Antistick). Its devices cite 1 predicate, 0 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 hospital panel, where it files most

How often FDA has decided Medsafe Asa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medsafe Asa since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Medsafe”

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