Company ยท US
Lexion Medical, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2019. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2019 | K191780 | AP50/30 Insufflator with Insuflow Port Lexion Medical, LLC | HIF |
| Nov 14, 2017 | K170799 | AP 50/30 Insufflator with Insuflow Port Lexion Medical, LLC | HIF |
| Mar 5, 2014 | K140263 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT Lexion Medical, LLC | HIF |
| Sep 20, 2013 | K132203 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA Lexion Medical, LLC | HIF |
| Aug 22, 2013 | K132204 | INSUFLOW SYNERGY XL PORT Lexion Medical, LLC | HIF |
| Jul 18, 2012 | K120640 | INSUFLOW SYNERGY PORT Lexion Medical, LLC | HIF |
| Nov 10, 2011 | K112357 | VESSEL GUARDIAN Lexion Medical, LLC | HIF |
| Sep 27, 2010 | K102136 | VESSEL GUARDIAN Lexion Medical, LLC | HIF |
| Jun 24, 2010 | K101320 | VASOVAPOR Lexion Medical, LLC | HIF |
| Sep 3, 2009 | K091366 | INSUFLOW DEWHEART Lexion Medical, LLC | HIF |
| Aug 26, 2009 | K090456 | INSUFLOW Lexion Medical, LLC | HIF |
| Jul 23, 2009 | K090879 | INSUFLOW CO2IONSHIELD Lexion Medical, LLC | FCX |
| Jan 10, 2007 | K063546 | INSUFLOW DEVICE, MODEL 6198 Lexion Medical, LLC | HIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||