ImpediMed Limited is one of 16108 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
ImpediMed Limited - FDA 510(k) Cleared Devices
Recent clearances: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1), MySOZO Software version 6.0.1.2 (SW version 6.0.1.2), SOZO Pro
13
Total
13
Cleared
0
Denied
ImpediMed Limited has 13 FDA 510(k) cleared gastroenterology & urology devices. Based in San Diego, US.
Latest FDA clearance: Aug 2026. Active since 2011.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Impedimed, Inc. and Imedimed, Inc..
FDA 510(k) Regulatory Record - ImpediMed Limited
13 devices
Cleared
Aug 17, 2026
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
Gastroenterology & Urology
203d
Cleared
Jan 28, 2026
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
Gastroenterology & Urology
121d
Cleared
Oct 17, 2023
SOZO Pro
Gastroenterology & Urology
96d
Cleared
May 04, 2023
SOZO Pro
Gastroenterology & Urology
66d
Cleared
May 04, 2023
SOZO Pro
Gastroenterology & Urology
66d
Cleared
Apr 19, 2021
SOZO
Gastroenterology & Urology
145d
Cleared
Oct 02, 2020
SOZO Body Fluid Analyzer
Gastroenterology & Urology
298d
Cleared
Nov 25, 2019
SOZO
Gastroenterology & Urology
266d
Cleared
Apr 16, 2018
SOZO
Gastroenterology & Urology
90d
Cleared
Dec 22, 2017
SOZO
Cardiovascular
126d
Cleared
Aug 11, 2017
SOZO
Gastroenterology & Urology
29d
Cleared
May 31, 2013
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
Gastroenterology & Urology
109d
Cleared
Nov 04, 2011
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
Gastroenterology & Urology
592d