FDA 510(k) Applications Submitted by Bernard Horwath
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130201 |
01/28/2013 |
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM |
OTOTRONIX, LLC |
| K140263 |
02/03/2014 |
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT |
LEXION MEDICAL, LLC. |
| K140313 |
02/10/2014 |
STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM |
COAG MEDICAL LLC |
| K090456 |
02/23/2009 |
INSUFLOW |
LEXION MEDICAL, LLC. |
| K120640 |
03/02/2012 |
INSUFLOW SYNERGY PORT |
LEXION MEDICAL, LLC. |
| K140644 |
03/13/2014 |
PROCEM |
OTOTRONIX, LLC |
| K170799 |
03/17/2017 |
AP 50/30 Insufflator with Insuflow Port |
LEXION Medical LLC |
| K120958 |
03/30/2012 |
POSISEP AND POSISEP X HEMOSTAT DRESSINGS |
HEMOSTASIS, LLC |
| K090879 |
03/31/2009 |
INSUFLOW CO2IONSHIELD |
LEXION MEDICAL, LLC. |
| K150888 |
04/02/2015 |
Shape-HF Cardiopulmonary Testing System |
SHAPE MEDICAL SYSTEMS, INC |
| K091366 |
05/08/2009 |
INSUFLOW DEWHEART |
LEXION MEDICAL, LLC. |
| K101320 |
05/11/2010 |
VASOVAPOR |
LEXION MEDICAL, LLC. |
| K131626 |
06/04/2013 |
EXCELERON BACTERIAL FILTERS |
EXCELERON MEDICAL |
| K191780 |
07/02/2019 |
AP50/30 Insufflator with Insuflow Port |
Lexion Medical LLC |
| K092156 |
07/16/2009 |
CAD 12, COLONOSCOPY ASSIST DEVICE |
SOFTSCOPE MEDICAL TECHNOLOGIES, INC. |
| K132203 |
07/16/2013 |
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA |
LEXION MEDICAL, LLC. |
| K132204 |
07/16/2013 |
INSUFLOW SYNERGY XL PORT |
LEXION MEDICAL, LLC. |
| K102136 |
07/29/2010 |
VESSEL GUARDIAN |
LEXION MEDICAL, LLC. |
| K112357 |
08/16/2011 |
VESSEL GUARDIAN |
LEXION MEDICAL, LLC. |
| K122494 |
08/16/2012 |
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT |
HEMOSTASIS, LLC |
| K142348 |
08/22/2014 |
OsteoSeal Bone Hemostat |
HEMOSTASIS, LLC |
| K102459 |
08/27/2010 |
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE |
HEMOSTASIS, LLC |
| K122886 |
09/20/2012 |
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING |
HEMOSTASIS, LLC |
| K183193 |
11/19/2018 |
MREplus+ Software |
Resoundant Inc |
| K080032 |
01/07/2008 |
ENVOYCEM, MODEL 1640 |
ENVOY MEDICAL CORPORATION |
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