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
15265341526534Sterigenics US, LLC1N2026-01-01305 Enterprise Dr Lewis Center OH US 43035
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
1178471107166906K974028STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBINGMKO1998-01-21
1178471921352239K972774GAS PLASMA STERILIZATIONJWH1999-05-05
1178472037476326K963109HERITAGE HIP SYSTEMJDI1997-01-09
1178471008936520K962196NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESSJWH1996-08-23
1178471061789545K961378DELTA HIP PROSTHESISLWJ1996-10-08
1178471862611094K960626MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)JDI1996-04-18
1038431475684294K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
1178471822478407K960278COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENTJDI1996-07-25
1178471171789193K954744ZCH ALPHA SYSTEMJDI1996-01-23
1178471147107911K954698TRILOGY ACETABULAR COMPONENT 7MM OFFSETLPH1996-01-17
1178471544452653K941213SONGER CABLE SYSTEMJDQ1994-04-19
1178471582987960K934381APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERTJWH1995-02-08
1038431753360744K932553DISPOSABLE SUTURE PLACEMENT SYSTEMGCJ1994-05-12
1178471217833418K930831MG II POROUS KNEE SYSTEM FEMORAL COMPONENTSJWH1993-11-16
1040911821535253K925416SYMBIOSIS BONE MARROW BIOPSY NEEDLEGAA1993-02-23
1178471364783794K922071ZIMMER ANATOMIC HIP SYSTEMLPH1994-02-22
1178472070901083K913649MODULAR CALCAR REPLACEMENTJDI1991-11-13
1178471499040684K911572MG II POROUS COBAL T-CHROME FEMORAL COMPONENTJWH1991-07-01
1038471899027654K911109OPHTA SIL (R), LACHRYMAL INTUBATION SETSOKS1991-05-01
1178471661905114K883665COONRAD III TOTAL ELBOWJDC1989-02-03
1178471792159478K882494ELAN-E DISPOSALBE DRAPEKKX1988-07-08
1040911721014269K881787ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIREDQX1988-07-25
1038451302435559K881767VIGGO INSUFLONFOZ1988-08-24
1178471646127478K872019BI-ARTICULAR II HIP DEVICEKWY1987-07-21
1040911089358650K851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLOKNT1985-06-12
1178471390091176K834432ANTHRO-MODULAR TOTAL KNEEJWH1984-04-11
1178471084200684K833991BIPOLAR HIP DEVICEKWY1984-01-30
1178471132147155K830196CORSTREN COMPRESSION TUBE & PLATEKTT1983-03-25
1178471647168135K830121INSALL/BURSTEIN FIBER METAL CONDYLAR/KNEJWH1983-04-26
1178471667782959K821893ZIMMER METAL BACKED ACETABULAR CUPJDI1982-09-14
1178471856221017K812182MIAMI, PROTRUSIO RINGJDI1981-08-18
1178471985750994K811416MOORE HIP PROSTHESIS, PMMA COATEDKWL1981-08-12
1038431195778969K800823QUICK FILLDXT1980-04-29
1178471618846409K800142FUSON BONE PLUG, RADIOPAQUEJDS1980-02-19
1178471912245158K790987ZIMMER R TOTAL SHOULDER IIKWT1979-06-22
1178471028935829K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadLPH2019-11-05
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
1178471266634436K133476SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTIONHJO2014-02-12
1040911810050966K133203SINGLE-SITE PORTGCJ2014-05-09
1038431018545975K132894OPTIO-C ANTERIOR CERVICAL SYSTEMOVE2014-01-16
1038471018545975K132894OPTIO-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
1178471076405495K122529ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACEHSX2012-11-16
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
1178471690959774K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEDXT2011-12-15
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
1178471345909699K081768COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLESNAJ2008-12-23
1038471836797996K080282ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;GEI2008-02-15
1178471582639860K073515TRANS1 FACET SCREWMRW2008-03-11
1178471774851313K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESJDL2008-08-07
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
1178471160684493K052321VERSYS EPOCH FULLCOAT HIP PROSTHESISLPH2006-02-15
1038441077483190K043114KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBEKNT2004-12-10
1038432013550723K042796ENDOTINE TRANSBLEPH 3.0/3.5 DEVICEHWC2004-11-05
1178471028610430K042761WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIESKTT2004-11-17
1038431221719329K042078ENDOTINE FOREHEAD TRIPLE DEVICEHWC2004-08-27
1038431551694162K041835ENDOTINE MIDFACE B 4.5 DEVICEHWC2004-09-28
1178471324655960K040186ANSPACH MRI SAFE SURGICAL DRILL SYSTEMHBB2004-04-15
1038471404470660K033584ARTHROCARE ARTHROWANDSGEI2003-11-28
1038431797424132K032770ENDOTINE FOREHEAD DEVICEHWC2003-10-08
1038471693192362K030954ARTHROCARE PERCD SPINEWANDGEI2003-04-16
1178471609951454K030733MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIESLPH2003-05-01
1038471788857792K011279ENTEC EVAC PLASMA WANDGEI2001-07-19
1038471454005434K011083ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWANDHRX2001-06-28
1178471931699748BK850026
1178471111574510
1038441166151921
1178471461036877
1178471480390581
1040911820265666
1038471904509967

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI92009-12-04
JWH71999-05-05
JDI71997-01-09
LPH52019-11-05
HWC52006-06-12
NAY42013-07-30
KNT42004-12-10
MAX32018-09-26
DYB32016-11-17
MBI32015-03-25
DXT32011-12-15
KKX32010-11-09
DQY22018-05-15
DRA22016-08-07
GCJ22014-05-09
KDI22014-02-04
OVE22014-01-16
FPA22013-10-08
KTT22004-11-17
KWY21987-07-21
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
HJO12014-02-12
HQC12012-12-21
OOE12012-12-12
HSX12012-11-16
HSN12012-08-24
KMJ12012-08-10
NTE12011-05-23
FYA12010-12-23
KPJ12009-08-12
NAJ12008-12-23