Hidrex GmbH
FDA Regulatory Profile
Hidrex GmbH appears in FDA public data with 3 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1238-2017, Class III) was initiated on January 30, 2017. Its most recent 510(k) clearance was granted on April 8, 2015.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1238-2017 | Class III | Daavlin Aquex (DAAV1000) | January 30, 2017 |
| Z-1236-2017 | Class III | Hidrex USA DP450 | January 30, 2017 |
| Z-1237-2017 | Class III | Hidrex USA DVP1000 | January 30, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133033 | HIDREX PSP1000 | April 8, 2015 |