Barco Inc.
FDA Regulatory Profile
Barco Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1854-2022, Class II) was initiated on July 27, 2022. Its most recent 510(k) clearance was granted on April 10, 2015.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1854-2022 | Class II | Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) | July 27, 2022 |
| Z-0227-2016 | Class II | Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-22 | May 28, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K150821 | MDNG-3220 (Nio 3MP LED) | April 10, 2015 |