FDA applicant
Dekumed, Kunststofftechnik Degler GmbH
FDA records 1 decision for Dekumed, Kunststofftechnik Degler GmbH (Germany, DE) in 1993: 1 510(k) clearance. All are in product code KCZ (Prosthesis, Breast, External, Used With Adhesive). 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 Dekumed, Kunststofftechnik Degler GmbH’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dekumed, Kunststofftechnik Degler GmbH since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dekumed, Kunststofftechnik Degler 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) Report