FDA.reportPublic FDA data

LEXION MEDICAL, LLC.

Matched from indexed company URL: Lex Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21353483003631551LEXION MEDICAL, LLC.1N2026-01-01545 Atwater Cir Saint Paul MN US 55103
30035428723003542872Lex Pearce1N2026-01-013801 University Blvd, SE Albuquerque NM US 87106
30047305443004730544LEX PEARCE1N2026-01-013801 UNIVERSITY BLVD, SE Albuquerque NM US 87106
30052105793005210579Lex Pearce1N2026-01-013801 University Blvd, SE Albuquerque NM US 87106
30092473263009247326Lex Pearce1N2026-01-013801 University Blvd, SE Albuquerque NM US 87106
30129981493012998149LEXINGTON MEDICAL, INC.1N2026-01-0123 Crosby Drive Bedford MA US 01730
30158310873015831087Lex Pearce1N2026-01-013801 University Blvd, SE Albuquerque NM US 87106
30158694923015869492Lex Pearce1N2026-01-013801 University Blvd, SE Albuquerque NM US 87106
30158762733015876273Lex Pearce1N2026-01-013801 University Blvd, SE Albuquerque NM US 87106
15258971525897LEXAMED1N2020-04-25705 FRONT ST. Toledo OH US 43605
30113042053011304205LEXI CO., LTD.1N2020-04-252-11-1 Sugamo Toshima-ku Tokyo JP 170-0002

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2333091164658189P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWSMAX1999-02-02
2332982034924052K904553BONE STAPLE(S)JDR1990-12-21
2111551300427778K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)GAG2024-05-07
2111552052620628K222210AEON Endoscopic StaplerGDW2023-04-21
2111551524031230K201882AEON Endoscopic StaplerGDW2020-10-09
1171701642828506K192270LEva Pelvic Digital Health SystemHIR2019-11-22
585551922000563K191780AP50/30 Insufflator with Insuflow PortHIF2019-08-28
2111551611384547K182380AEON Endoscopic StaplerGDW2018-11-28
1171701323790154K181863Elvie PumpHGX2018-10-10
1616341023348081K181204RENASYS Y-Connector; RENASYS TOUCHOMP2019-01-10
1616341309561124K180406Ellipse YdunGEX2018-03-15
2111551177213968K180114AEON Retrieval BagGCJ2018-03-27
2111551490125508K171589AEON Endoscopic StaplerGDW2017-11-17
585551311632653K170799AP 50/30 Insufflator with Insuflow PortHIF2017-11-14
1171701136860744K163002Kangaroo Feeding Tube with IRIS TechnologyKNT2017-05-16
1349701136860744K163002Kangaroo Feeding Tube with IRIS TechnologyKNT2017-05-16
2111551160370451K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and ReloadGDW2017-02-09
1616341597834641K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power SupplyOMP2016-08-04
1349701968689802K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalLZH2016-07-06
1616341309970773K152163RENASYS GOOMP2016-09-29
1171701312288120K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleERL2015-08-14
1349701312288120K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleERL2015-08-14
1616341462898154K143115The VersaJet II Hydrosurgery SystemFQH2015-07-15
1616341790328373K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX CanistersOMP2015-04-29
585551161069665K140263INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORTHIF2014-03-05
1757661437306912K133022ZEDVIEWLLZ2014-03-06
585551125174223K132204INSUFLOW SYNERGY XL PORTHIF2013-08-22
585551739286858K132203PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULAHIF2013-09-20
1171701168196216K123555KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGYKNT2014-04-09
585551545093419K120640INSUFLOW SYNERGY PORTHIF2012-07-18
585551872353269K102136VESSEL GUARDIANHIF2010-09-27
585551637213038K091366INSUFLOW DEWHEARTHIF2009-09-03
1616341647275002K083375RENASYS GO NEGATIVE PRESSURE WOUND THERAPYOMP2009-02-25
1171701919208060K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPILO2008-05-08
585551225245928K063546INSUFLOW DEVICE, MODEL 6198HIF2007-01-10
1616341077465548K031199ENTERALITE INFINITY ENTERAL FEEDING PUMPLZH2003-07-09
796751366306168
1616341519146855
1616341538986748
796751767239662
1616341790348316
1616341953866292
1349701000952446
2332981002336398
2333091003424706
2333091009611813
1171701014645067
1616341015700022
1616341023984931
2333091024165002
2333091025864319
2333091028577720
1616341031736250
2332981031935470
2333031035184046
1171701037131198
2333031047287229
1349701053340948
2333091056910659
2333091058405348
1171701064282667
2333091064297695
1616341064548742
2333031066832033
2333031067587801
2333091071064684
2333091073525280
2332981074481682
585551077669518
1171701077984102
2333091079895496
2332981084865772
2333091085130456
2333031086393591
2333031087455312
2333091087704240
2333031089680379
2333031091235909
2333031091675248
2333031097488947
2333091098105499
2333031099065373
2333091099065373
1616341103452078
2333031104114700
1616341105413843
2333031110749403
1171701121570413
1616341122111279
2332981125658188
1171701128537968
1616341128537968
2333091131413882
1349701132614631
2332981136663246
2333031136663246
3279111140692218
2332981145677945
1616341145882651
2333031150795071
2332981159079082
1616341160405120
1349701168196216
1171701169594756
2333091173789891
2332981174863930
2333091175145266
2333031175545282
2333031177702049
2333031178778463
2333091181261273
2332981181499576
1171701186830372
2333091192371927
2333091197623728
2332981204273746
2333031204273746
2333091206591352
1616341207933061
1616341210878471

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIF92019-08-28
GDW52023-04-21
OMP52019-01-10
KNT32017-05-16
LZH22016-07-06
ERL22015-08-14
GAG12024-05-07
HIR12019-11-22
HGX12018-10-10
GCJ12018-03-27
GEX12018-03-15
FQH12015-07-15
LLZ12014-03-06
ILO12008-05-08
MAX11999-02-02
JDR11990-12-21

NDC#

Xermelo

Lexicon Pharmaceuticals, Inc.

telotristat ethyl

Xermelo

Lexicon Pharmaceuticals, Inc.

telotristat ethyl

INPEFA

Lexicon Pharmaceuticals, Inc.

sotagliflozin

INPEFA

Lexicon Pharmaceuticals, Inc.

sotagliflozin

INPEFA

Lexicon Pharmaceuticals, Inc.

sotagliflozin

PMN#

MRS-2D

1996-10-31

LEXICOR MEDICAL TECHNOLOGY, INC.

Applications#