Company ยท AU
ImpediMed Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (2 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 17, 2026 | K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) ImpediMed Limited, AU | DSB |
| Jan 28, 2026 | K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) ImpediMed Limited, AU | OBH |
| Oct 17, 2023 | K232089 | SOZO Pro ImpediMed Limited, AU | DSB |
| May 4, 2023 | K230531 | SOZO Pro ImpediMed Limited, AU | QJB |
| May 4, 2023 | K230530 | SOZO Pro ImpediMed Limited, AU | OBH |
| Apr 19, 2021 | K203473 | SOZO ImpediMed Limited, AU | DSB |
| Oct 2, 2020 | K193410 | SOZO Body Fluid Analyzer ImpediMed Limited, AU | DSB |
| Nov 25, 2019 | K190529 | SOZO ImpediMed Limited, AU | QJB |
| Apr 16, 2018 | K180126 | SOZO ImpediMed Limited, AU | OBH |
| Dec 22, 2017 | K172507 | SOZO ImpediMed Limited, AU | DSB |
| Aug 11, 2017 | K172122 | SOZO ImpediMed Limited, AU | OBH |
| May 31, 2013 | K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS ImpediMed Limited | OBH |
| Nov 4, 2011 | K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 ImpediMed Limited | OBH |
| Oct 3, 2008 | K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 Impedimed Pty , Ltd., AU | OBH |
| Mar 30, 2007 | K050415 | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS Impedimed Pty , Ltd., AU | OBH |
| Apr 4, 2006 | K052319 | IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 Impedimed Pty , Ltd., AU | MNW |
| Jul 13, 2005 | K050395 | IMPEDIMED - BODY COMPOSITION ANALYSIS Impedimed Pty , Ltd., AU | MNW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2023 | Impedimed Limited SOZO Bilateral Arm L-Dex Software Open, Classified |
OBH | K180126 |