Instrumentarium Dental, PaloDEx Group Oy
Instrumentarium Dental, PaloDEx Group Oy appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1091-2014, Class II) was initiated on January 14, 2014. Its most recent 510(k) clearance was granted on March 20, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1091-2014 | Class II | The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) | January 14, 2014 |