FDA applicant
Noras Mri Products GmbH
FDA records 10 decisions for Noras Mri Products GmbH (Hoechberg, DE) from 2008 to 2024: 10 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 59 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 2 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
How often FDA has decided Noras Mri Products GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Noras Mri Products GmbH’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 “Noras”
FDA records each applicant name separately; these may or may not be the same firm.