Enraf-Nonius, B.V.
FDA Regulatory Profile
Enraf-Nonius, B.V. appears in FDA public data with 0 recalls, 5 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on September 12, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251083 | Compact II | September 12, 2025 |
| K243112 | Curapuls 670 | June 25, 2025 |
| K230472 | Sonopuls 190 | October 24, 2023 |
| K151640 | ELTRAC 471 | October 16, 2015 |
| K030297 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 | April 28, 2003 |