Magnolia Medical Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0318-2022 | Class II | The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 | November 2, 2021 |
| Z-2393-2021 | Class II | Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be u | August 2, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251812 | Steripath® Flow Blood Collection System | September 25, 2025 |
| K222299 | Steripath Micro Blood Collection System | November 30, 2022 |
| K200661 | Steripath Micro Blood Collection System | October 8, 2020 |
| K192247 | Steripath Gen2 Blood Collection System | February 28, 2020 |