Aap Biomaterials GmbH
FDA Regulatory Profile
Aap Biomaterials GmbH has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 6, 2018 · OAI
- Latest 510(k)
- Oct 19, 2012
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3005568854 | Dieburg, Germany | 2 | Sep 6, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K121876 | VERTECEM II CEMENT KIT | Oct 19, 2012 |
| K090460 | BONOS INJECT | Apr 14, 2009 |