FDA applicant

Syntheticmr AB (Publ.)

Linköping, SE2 decisions2024–20240 recalls

FDA records 2 decisions for Syntheticmr AB (Publ.) (Linköping, SE) in 2024: 2 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 2 predicates, 1 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, radiology panel, where it files most

How often FDA has decided Syntheticmr AB (Publ.)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Syntheticmr AB (Publ.) by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Syntheticmr AB (Publ.)’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 “Syntheticmr”

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

Syntheticmr AB 6

Syntheticmr AB (Publ.)

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Syntheticmr”