Impedimed Limited
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0155-2024 | Class II | SOZO Bilateral Arm L-Dex Software | August 17, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | January 28, 2026 |
| K232089 | SOZO Pro | October 17, 2023 |
| K230531 | SOZO Pro | May 4, 2023 |
| K230530 | SOZO Pro | May 4, 2023 |
| K203473 | SOZO | April 19, 2021 |
| K193410 | SOZO Body Fluid Analyzer | October 2, 2020 |
| K190529 | SOZO | November 25, 2019 |
| K180126 | SOZO | April 16, 2018 |
| K172507 | SOZO | December 22, 2017 |
| K172122 | SOZO | August 11, 2017 |
| K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | May 31, 2013 |
| K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | November 4, 2011 |