FDA applicant
Quality Electrodynamics, LLC
FDA records 34 decisions for Quality Electrodynamics, LLC (Mayfield Village, OH) from 2007 to 2025: 34 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 42 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 21 of them its own earlier devices. 9 recalls are linked to its devices.
FDA’s records also spell it “Quality Electrodynamics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Quality Electrodynamics, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
7in 2019
Class I Class II/III not classified
Planning a device like Quality Electrodynamics, LLC’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) Report