Hartmann USA, Inc
FDA Regulatory Profile
Hartmann USA, Inc appears in FDA public data with 2 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1857-2012, Class II) was initiated on May 14, 2012. Its most recent 510(k) clearance was granted on December 9, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1857-2012 | Class II | Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponge | May 14, 2012 |
| Z-1858-2012 | Class II | Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 tot | May 14, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242758 | Atrauman® Ag | December 9, 2024 |