FDA applicant
Ec Certification Service GmbH
FDA records 1 decision for Ec Certification Service GmbH (Sankt Veit An Der Glan, AT) in 2025: 1 510(k) clearance. All are in product code DYW (Bracket, Plastic, Orthodontic). Its devices cite 1 predicate, 0 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 Ec Certification Service GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Ec Certification Service 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