FDA applicant
NGMedical GmbH
FDA records 7 decisions for NGMedical GmbH (Nonnweiler, DE) from 2021 to 2026: 7 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 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 NGMedical 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 2021.
Planning a device like NGMedical 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