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Lexion Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K191780AP50/30 Insufflator with Insuflow PortAugust 28, 2019
K170799AP 50/30 Insufflator with Insuflow PortNovember 14, 2017
K140263INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORTMarch 5, 2014
K132203PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULASeptember 20, 2013
K132204INSUFLOW SYNERGY XL PORTAugust 22, 2013
K120640INSUFLOW SYNERGY PORTJuly 18, 2012
K112357VESSEL GUARDIANNovember 10, 2011
K102136VESSEL GUARDIANSeptember 27, 2010
K101320VASOVAPORJune 24, 2010
K091366INSUFLOW DEWHEARTSeptember 3, 2009
K090456INSUFLOWAugust 26, 2009
K090879INSUFLOW CO2IONSHIELDJuly 23, 2009
K063546INSUFLOW DEVICE, MODEL 6198January 10, 2007