Home › Device types › OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
FDA product code OBH · Class 2 · Cardiovascular
12
Registered devices
0
Adverse events
1
Recalls
10
510(k) clearances
Devices with this code
SOZOThrive — IMPEDIMED LIMITEDL-Dex® U400 — IMPEDIMED LIMITEDSOZO Body Fluid Analyzer — IMPEDIMED LIMITEDSOZO Body Fluid Analyzer — IMPEDIMED LIMITEDSOZO Body Fluid Analyzer — IMPEDIMED LIMITEDMYSOZO.com — IMPEDIMED LIMITEDSOZOapplication — IMPEDIMED LIMITEDL-Dex® U400 — IMPEDIMED LIMITEDSOZO Body Fluid Analyzer — IMPEDIMED LIMITEDL-Dex® U400 — IMPEDIMED LIMITEDSOZO Body Fluid Analyzer — IMPEDIMED LIMITEDU400 ImpSoft Software — IMPEDIMED LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-17 | Impedimed Limited | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, |
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