FDA applicant
Eastman Kodak Company
FDA records 238 decisions for Eastman Kodak Company (Rochester, NY) from 1977 to 2006: 238 510(k) clearances. Most are in product codes IXW (Processor, Radiographic-Film, Automatic) and JJE (Analyzer, Chemistry (Photometric, Discrete)…). Its devices cite 17 predicates, 4 of them its own earlier devices. 66 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Eastman Kodak Company’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Eastman Kodak Company since 2007.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Eastman Kodak Company’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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