FDA applicant
Hager& Meisinger GmbH
FDA records 14 decisions for Hager& Meisinger GmbH (Neuss, DE) from 2007 to 2025: 14 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and DZL (Screw, Fixation, Intraosseous). Since 2016 its 510(k)s took a median of 223 days from receipt to decision, against 213 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 10 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 Hager& Meisinger 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 2007.
Planning a device like Hager& Meisinger 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) ReportOther applicant names beginning “Hager&”
FDA records each applicant name separately; these may or may not be the same firm.