FDA.reportPublic FDA data

Sterigenics US LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10585841000219637Sterigenics US LLC1N2026-01-0110811 Withers Cove Park Drive Charlotte NC US 28278
14236623000215273Sterigenics US LLC1N2026-01-011003 Lakeside Drive Gurnee IL US 60031
16495183001236277Sterigenics US LLC1N2026-01-013125 Wichita Court Fort Worth TX US 76140
20111712011171Sterigenics US LLC1N2026-01-014900 Gifford Ave Los Angeles CA US 90058
30029076203002907620Sterigenics US LLC1N2026-01-011700 College Blvd. West Memphis AR US 72301
30041115733004111573Sterigenics US LLC1N2026-01-011302 Avenue T Grand Prairie TX US 75050

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1040911451194799P120023KAMRA INLAYLQE2015-04-17
1038471831049149P020012ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLERLMH2006-10-27
1038441305387897K993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1999-10-20
1038441549050430K982894MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1998-09-11
1038431475684294K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
1038431753360744K932553DISPOSABLE SUTURE PLACEMENT SYSTEMGCJ1994-05-12
1040911821535253K925416SYMBIOSIS BONE MARROW BIOPSY NEEDLEGAA1993-02-23
1038471899027654K911109OPHTA SIL (R), LACHRYMAL INTUBATION SETSOKS1991-05-01
1040911721014269K881787ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIREDQX1988-07-25
1038451302435559K881767VIGGO INSUFLONFOZ1988-08-24
1040911089358650K851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLOKNT1985-06-12
1038431195778969K800823QUICK FILLDXT1980-04-29
1038471283940713K181591Fixated Asfora BULLET CAGE® (FABC)MAX2018-09-26
1038431567954022K180986XableCath Support Catheter Product FamilyDQY2018-05-15
1038431227345634K170041XableCath Support CatheterDQY2017-09-07
1040911244848410K162097InTRAkitDYB2016-11-17
1040911562681748K162027TRAcelet Compression DeviceDXC2016-10-21
1040911651333214K161985Steerable Guide CatheterDRA2016-08-07
1038471787253281K161266Athena Breast PumpHGX2016-08-11
1038451475598044K160846AmplifEYEFED2016-07-14
1040911987161394K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMAV2016-04-13
1038471659641598K152574NavioOLO2015-10-20
1038431681907139K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMUU2015-05-22
1038471091962644K150321EVOS Lumbar Interbody SystemMAX2015-07-13
1038471749846223K143479Bluefin Interbody SystemMAX2015-09-25
1040911755997530K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needlesMBI2015-03-25
1040911998793783K142199Ascendra Balloon Aortic Valvaloplasty CatheterOZT2014-10-29
1038441616704575K141110CRYOCARE CS SURGICAL SYSTEMGEH2015-06-25
1040911544069185K133983INTRA. OX HANDHELD TISSUE OXIMETERMUD2014-09-12
1040911810050966K133203SINGLE-SITE PORTGCJ2014-05-09
1038471018545975K132894OPTIO-C ANTERIOR CERVICAL SYSTEMOVE2014-01-16
1038431018545975K132894OPTIO-C ANTERIOR CERVICAL SYSTEMOVE2014-01-16
1038441852412441K132602STREAMLINE EXPRESSKDI2014-02-04
1038452059533206K132142NERIA SOFT 90 INFUSION SETFPA2013-10-08
1040911775361467K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
1038441152908680K123120LENSX LASER SYSTEMOOE2012-12-12
1038451228764431K122686ACCU-CHEK ULTRAFLEX INFUSION SETFPA2012-11-16
1040911746613440K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESNAY2013-07-30
1038441535011942K121555CENTURION VISION SYSTEMHQC2012-12-21
1038441466626225K121390LUBE JELLY SURINGEKMJ2012-08-10
1040911528973297K121234GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATINGDYB2012-11-20
1038471217399821K120906ZIMMER TRABECULAR METAL TOTAL ANKLEHSN2012-08-24
1040911926199708K120428GORE DRYSEAL SHEATHDYB2012-04-20
1038431690959774K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEDXT2011-12-15
1038441459476067K113023STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZERKDI2012-12-21
1040911771166446K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
1040911544936905K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
1040911452181969K103500GORE EMBOLIC FILTERNTE2011-05-23
1038451108421637K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSFYA2010-12-23
1038452049071897K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKKX2010-11-09
1038471119108531K093165ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDSGEI2009-12-04
1038441852095923K090681TANSCU O2KPJ2009-08-12
1038471007563962K090393ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144GEI2009-06-23
1040911294799119K083793STEERABLE GUIDE CATHETERDRA2009-04-27
1038471208327210K083306MODIFICATION TO ARTHROCARE ARTHROWANDSGEI2008-12-10
1038451253867898K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
1038471836797996K080282ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;GEI2008-02-15
1038471564705420K072345POWRSYRINGE MONITORFMF2007-09-21
1038441605252237K072315MIDAS REX CURVED BURHBE2007-09-18
1038471854841064K071442SUPRASORB A +AGFRO2008-05-01
1038471050175793K070374ARTHROCARE ENT PLASMA WANDGEI2007-04-25
1038471086247833K070227OPUS MAGNUM PI KNOTLESS FIXATION DEVICEMBI2007-04-16
1038471194876168K063172ARTHROCARE CAVITY SPINEWANDGEI2007-04-27
1038471233371680K061349OPUS LABRALOCK P KNOTLESS FIXATION DEVICEMBI2006-07-14
1038431085888170K060828MODIFICATION TO ENDOTINE RIBBONGAM2006-04-19
1038431237776925K060249ULTRATINE FOREHEADHWC2006-06-12
1038441077483190K043114KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBEKNT2004-12-10
1038432013550723K042796ENDOTINE TRANSBLEPH 3.0/3.5 DEVICEHWC2004-11-05
1038431221719329K042078ENDOTINE FOREHEAD TRIPLE DEVICEHWC2004-08-27
1038431551694162K041835ENDOTINE MIDFACE B 4.5 DEVICEHWC2004-09-28
1038471404470660K033584ARTHROCARE ARTHROWANDSGEI2003-11-28
1038431797424132K032770ENDOTINE FOREHEAD DEVICEHWC2003-10-08
1038471693192362K030954ARTHROCARE PERCD SPINEWANDGEI2003-04-16
1038471788857792K011279ENTEC EVAC PLASMA WANDGEI2001-07-19
1038471454005434K011083ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWANDHRX2001-06-28
1038441166151921
1040911820265666
1038471904509967
1038441977213677
1038432012214262
1038451000271196
1038451001099676
1040911001301551
1038451001734266
1038441001891711
1038471001987561
1050401002320969
1038441002320969
1038471002320969
1038441003664127
1038451003664127
1050401004549274
1038431004595809
1038441005334568
1038471005456165
1038441005505673
1038451005720321
1040911005879226
1038451007770293
1038431008099469
1038451008855853
1038451008973490
1040911009443524
1038451009832186
1050401010715873
1038451011713405
1040911011891734
1040911012456890
1038431012677825
1038471012677825
1038451012754900
1040911012914936
1038451013046016
1038471013115493
1038471014062522
1038431014062522
1050401014124279
1040911014170367
1040911014586711
1038441014672222

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI92009-12-04
HWC52006-06-12
NAY42013-07-30
KNT42004-12-10
MAX32018-09-26
DYB32016-11-17
MBI32015-03-25
DQY22018-05-15
DRA22016-08-07
GCJ22014-05-09
KDI22014-02-04
OVE22014-01-16
FPA22013-10-08
DXT22011-12-15
KKX22010-11-09
DXC12016-10-21
HGX12016-08-11
FED12016-07-14
MAV12016-04-13
OLO12015-10-20
GEH12015-06-25
MUU12015-05-22
LQE 12015-04-17
OZT12014-10-29
MUD12014-09-12
HQC12012-12-21
OOE12012-12-12
HSN12012-08-24
KMJ12012-08-10
NTE12011-05-23
FYA12010-12-23
KPJ12009-08-12
FRO12008-05-01
FMF12007-09-21
HBE12007-09-18
LMH12006-10-27
GAM12006-04-19
HRX12001-06-28
KNW11996-04-04
GAA11993-02-23