FDA applicant
Dr. Franz Kohler Chemie GmbH
FDA records 5 decisions for Dr. Franz Kohler Chemie GmbH (Brookeville, MD) from 1999 to 2020: 5 510(k) clearances. Most are in product codes KDL (Set, Perfusion, Kidney, Disposable) and MSB (System And Accessories, Isolated Heart…). Its devices cite 8 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dr. Franz Kohler Chemie GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
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