Dufner Instrumente GmbH
FDA Regulatory Profile
Dufner Instrumente GmbH appears in FDA public data with 1 recall, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2534-2020, Class II) was initiated on June 3, 2020. Its most recent 510(k) clearance was granted on February 5, 2001.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2534-2020 | Class II | DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing w | June 3, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K002877 | MICTEC ENDOSCOPES AND ACCESSORIES | February 5, 2001 |