FDA applicant
Aap Implantate AG
FDA records 37 decisions for Aap Implantate AG (Berlin, DE) from 1999 to 2026: 37 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 94 predicates, 21 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 Aap Implantate AG’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Aap Implantate AG’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