FDA.reportPublic FDA data

LION CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30023432533002343253LION CORPORATION1N2026-01-013-28, Kuramae 1-chome Taito-ku Tokyo JP 1118644
30099184643009918464LION DAILY NECESSITIES CHEMICALS (QINGDAO) CO., LTD1N2026-01-01No 919 Weihe Road Qingdao Economic & Technical Development Zone Qingdao Shandong CN 266555
00LIONSER MEDICAL DISNFECTANT(HANGZHOU)CO.,LTD5N2020-04-25No.1 Langsuo Road,Jiande Hangzhou Zhejiang CN 311607
30040099093004009909LIONSHEAD PRECISION METALS, LLC.1N2020-04-256136 E Hanna Ave Indianapolis IN US 46203
30115111123011511112LION HEALTHCARE1N2020-04-25Suite B, 8 Welshpool Road East Victoria Park West Perth Western Australia AU 6101
30142748583014274858LION HEART SURGICAL SUPPLY1Y2020-04-252130 Van Buren St Hollywood FL US 33020

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2162401006849398K963359INSUFFLATION NEEDLEHET1996-09-24
2162401170936808K831648ANCHOR BRAND SURGICAL NEEDLESGAB1983-08-16
2162401224473739K163523ECHELON CIRCULAR Powered StaplerGDW2017-04-18
2162401632551577K161514Precision Thin Reciprocating Blade, 0.010in.EQJ2017-01-17
2162401394700160K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX2016-03-24
2162401297643795K143541Relieva SpinPlus Balloon Sinuplasty SystemLRC2015-04-22
2162401415807209K141952ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCEDGDW2014-11-24
2162401774021209K141888RUSCH ENDOBRONCHIAL TUBESCBI2015-04-15
2162402019930225K140521TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCHGEI2014-06-10
2162401188547179K122797ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAWGEI2013-01-25
2162401852725993K113268ALEXIS O WOUND PROTECTOR/RETRACTORKGW2013-02-08
2162401087589443K111444UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSIONHSB2011-06-22
2162401959010463K091659BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732FTL2009-08-03
2162401640916648K090877PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWSHRS2009-06-26
2162401607583877K0904921.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWSHRS2009-03-31
2162401033251453K061903RELIEVA SINUS BALLOON CATHETERLRC2006-08-18
2162401436674729K061156ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERSGDW2006-07-03
2162401498153131K043442STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAEGXI2005-05-31
2162401803276418K042325TROCHANTERIC NAIL SYSTEMHSB2004-09-08
2162401249130680K032889OPTICAL SEPARATORGCJ2003-10-02
2162401646607016K023013STRYKER XCEL ANCHOR SYSTEMHWC2003-02-26
2162401294970648K021808WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIERFZP2002-08-14
2162401472628677K013563LONG TROCHANTERIC NAIL SYSTEMHSB2001-12-27
2162401115849172
2043531210751671
1776091611803665
2162401612285030
2162401658946136
2463102024989905
1461281304809910
1605291509626605
1605291841533063

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GDW32017-04-18
HSB32011-06-22
LRC22015-04-22
GEI22014-06-10
HRS22009-06-26
EQJ12017-01-17
NCX12016-03-24
CBI12015-04-15
KGW12013-02-08
FTL12009-08-03
GXI12005-05-31
GCJ12003-10-02
HWC12003-02-26
FZP12002-08-14
HET11996-09-24
GAB11983-08-16

NDC#