FDA.reportPublic FDA data

Sterigenics U.S., LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10184701018470Sterigenics U.S., LLC1N2026-01-012971 Olympic Industrial Dr SE Ste 116 Atlanta GA US 30339
10368361036836Sterigenics U.S., LLC1N2026-01-011148 Porter Ave Haw River NC US 27258
10611241000512168Sterigenics U.S., LLC1N2026-01-0110821 Withers Cove Park Dr Charlotte NC US 28278
13196391000138054Sterigenics U.S., LLC1N2026-01-0184 Park Rd Queensbury NY US 12804
14200321420032Sterigenics U.S., LLC1N2026-01-01711 Cooper Ct Schaumburg IL US 60173
17216761721676Sterigenics U.S., LLC1N2026-01-015725 Harold Gatty Dr Salt Lake City UT US 84116
17216861721686Sterigenics U.S., LLC1N2026-01-012400 Airport Rd Santa Teresa NM US 88008
20224352022435Sterigenics U.S., LLC1N2026-01-011401 Morgan Cir Tustin CA US 92780
20290151000160458Sterigenics U.S., LLC1N2026-01-01687 S Wanamaker Ave Ontario CA US 91761
20292751000306431Sterigenics U.S., LLC1N2026-01-01344 Bonnie Cir Corona CA US 92878
22199202219920Sterigenics U.S., LLC1N2026-01-01108 Lake Denmark Rd Rockaway NJ US 07866
22455902245590Sterigenics U.S., LLC1N2026-01-0175 Tilbury Rd Salem NJ US 08079

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1469001903635359P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS2012-09-28
1469231949820517P020014ESSURE SYSTEMHHS2002-11-04
1469081264859005K990707MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERSDQY1999-03-22
1469081356020224K981198MEDTRONIC ZUMA GUIDING CATHETERDQY1998-08-07
1467871509636781K962907SKINNY,FRANSEEN,WESCOTT NEEDLESKNW1996-10-23
1469171575218025K960248GENERAL PROCEDURE KITFMF1996-04-12
1469001250393281K953939QUINTESTSCL1995-11-13
1469171550205863K945484PIDURAL STEROID SYSTEMCAZ1995-06-02
1469071152548613K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
1469071821535253K925416SYMBIOSIS BONE MARROW BIOPSY NEEDLEGAA1993-02-23
1469081067383154K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDUDTR1990-04-20
1469172011091690K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)DXT1989-04-18
1469001089358650K851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLOKNT1985-06-12
1469171033676125K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)GAT2018-08-01
1469171245942970K180919GORE Tri-Lumen CatheterDQY2018-10-05
1469171857028970K180531NovoStitch Pro Meniscal Repair SystemGAT2018-03-29
1469171916673646K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterQEW2018-05-15
1469171098660022K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump CanisterQEW2018-03-08
1469171572950557K180008Penumbra SystemNRY2018-06-20
1469001122124148K170827INTRACEPT Intraosseous Nerve Ablation SystemGXI2017-08-09
1469171852249263K163693IntraClude Intra-Aortic Occlusion DeviceDXC2017-01-26
1469001367135230K161189Integra TITAN Reverse Shoulder SystemPHX2016-08-25
1469002007468113K161033AFX™ Femoral Implant With InserterMBI2016-08-03
1467871433661147K160450Pleurx Pleural Catheter SystemDWM2016-10-31
1467871301231889K160437PleurX Peritoneal Catheter SystemPNG2016-11-03
1488571418782165K143316Attain Hybrid Guide WireDQX2015-03-11
1469001510554206K142413TITAN Modular Total Shoulder SystemKWS2014-11-14
1469001562853336K141848IOGYN SYSTEMPGT2014-08-29
1469171763361919K141484OPEN FMSEALERGEI2014-07-30
1469171916763993K140775TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEMMCW2014-07-23
1469001575095871K140657CUROS RED PORT PROTECTORQBP2014-12-04
1488451635294360K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
1488451676421904K1338458MM TROCAR KITGCJ2014-02-19
1469081496794882K133026UNBALLOON NON-OCCLUSION MODELING CATHETERDQY2013-12-31
1469281209095526K131654STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERNEU2013-06-27
1469171235958801K131627CATHETER INTRODUCER SHEATHDYB2014-03-06
1469001811435414K131345TIARRAY DENTAL IMPLANT SYSTEMDZE2013-08-07
1469001426055964K130124CATALYST II AND IIIDXC2013-03-14
1469172010843490K123370EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULADWF2013-03-13
1469171428511254K123303FEMORAL ACCESS VENOUS CANNULAEDWF2013-03-22
1469171566010664K123298FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATINGDWF2013-03-15
1469171572987019K123187RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULADWF2013-02-22
1469171597219013K122190PRELUDE 7F SHORT SHEATH INTRODUCERDYB2012-08-17
1469081160669935K121839UNBALLOON NON-OCCLUSIVE MODELING CATHETERDQY2012-08-08
1469081355210852K121525PERIFUSE CATHETERCAZ2012-08-02
1469001786648396K121171CUROS TIPQBP2012-11-26
1469171056791156K120964UPSTREAM GR CATHETERDQY2012-05-25
1469171651025018K120780EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICEDWF2012-06-27
1469001009473986K120732LENSSX LASER SYSTEMHQC2012-09-06
1469171331966163K120548HLIC NEEDLE-LESS VALVEFPA2012-05-04
1469171257844926K120072VENOUS DRAINAGE CANNULA WITH DURAFLO COATINGDWF2012-05-08
1469001036316924K113706ENDOWRIST STAPLER SYSTEMNAY2012-10-17
1469171406015337K113411EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULADWF2012-06-11
1469251287062926K113333KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTSBTR2012-05-11
1469171005419720K112887UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTORDYB2012-03-21
1469001771166446K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
1488451060109113K111992CUROS PORT PROTECTORQBP2012-01-12
1467871108421637K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSFYA2010-12-23
1469251108421637K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSFYA2010-12-23
1469071108421637K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSFYA2010-12-23
1469072049071897K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKKX2010-11-09
1467872049071897K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKKX2010-11-09
1469252049071897K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKKX2010-11-09
1469001864082249K101626LENSX LASER SYSTEMOOE2010-10-18
1469001694796695K094052LENSX 550 LASER SYSTEM. MODEL 550OOE2010-04-23
1469001416268296K093899MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGINGKNW2010-04-29
1488571102023659K093352HG III FIXTURE SYSTEMDZE2009-11-24
1469141102023659K093352HG III FIXTURE SYSTEMDZE2009-11-24
1469171476920973K093257TORQMAX SHEATH GRIP ACCESSORYOFC2010-03-26
1469171958079457K092666INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250HCG2009-09-30
1469001282471218K092647LENSX 550 LASER SYSTEMOOE2009-12-11
1467871235126004K091343MRI NEURO DRAPEKKX2009-09-22
1488571604782778K090237HG II FIXTURE SYSTEMDZE2009-04-17
1469141604782778K090237HG II FIXTURE SYSTEMDZE2009-04-17
1469071253867898K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
1469231253867898K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
1469251253867898K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
1467871253867898K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
1488571820952413K083067MS SYSTEMDZE2009-02-02
1469141820952413K083067MS SYSTEMDZE2009-02-02
1469001694094868K082947LENSX 550 LASER SYSTEMOOE2009-08-14
1488572033942832K082213GS III FIXTURE SYSTEMDZE2008-10-14
1469142033942832K082213GS III FIXTURE SYSTEMDZE2008-10-14
1469251698372570K080821MICROCUFF PEDIATRIC ENDOTRACHEAL TUBEBTR2008-04-22
1488571673090710K080594MS SYSTEM (NARROW RIDGE)DZE2008-09-03
1469141673090710K080594MS SYSTEM (NARROW RIDGE)DZE2008-09-03
1469141429171834K080387HU II / HS II FIXTURE SYSTEMDZE2008-03-07
1488571429171834K080387HU II / HS II FIXTURE SYSTEMDZE2008-03-07
1469171207748929K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIDQR2008-01-31
1469141245616257K073465US/GS ULTRA WIDE SYSTEMDZE2008-04-07
1488571245616257K073465US/GS ULTRA WIDE SYSTEMDZE2008-04-07
1469141438626026K072959MS SYSTEM (DENTURE)DZE2008-02-04
1488571438626026K072959MS SYSTEM (DENTURE)DZE2008-02-04
1469081644559147K072419ADVANTIV SAFETY I.V. CATHETERFOZ2007-11-09
1469171285466783K071604ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEMJCT2007-09-19
1469001985371237K063346PRO OSTEON 500RMQV2007-04-18
1469001460719041K062653MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098LFD2006-10-27
1469171592288082K062511AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XXJCT2007-01-31
1469081740248329K0624205F SHERPA ACTIVE NX GUIDE CATHETERDQY2006-09-08
1469171517498954K062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135DQO2006-08-09
1469071520130490K060534INTUITIVE SURGICAL SEALGCJ2006-03-13
1469171412626771K060523NEUROPORT NEURAL SIGNAL PROCESSING SYSTEMOMC2006-03-28
1469081972047032K0604188F SHERPA NX GUIDE CATHETERDQY2006-03-15
1469001770232611K051914GENEROS 80, GENEROS 60MQV2005-11-03
1469081066264295K0518467F SHERPA NX GUIDE CATHETERDQY2005-08-05
1469001856254918K051695MARROW PLUS (M+)MQV2005-07-19
1469171809570427K050962MERIT PRELUDE SHEATH INTRODUCERDRE2005-05-06
1469001557537864K050666GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIESMQV2005-04-11
1469001778878865K041889TRI-OSTETICMQV2004-08-19
1469001002680114K033700MAMMOTOME EX HAND HELD SYSTEMKNW2004-02-20
1469252062055080K033515HUBERPRO SAFETY HUBER INFUSION SETFPA2004-01-22
1469001880364032K0202768 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535NEU2002-04-12
1469002014276397K013413MICROMARK II TISSUE MARKER,MODEL C1535NEU2001-12-03
1469171332126718K011727TRANSSEPTAL NEEDLE/TROCARDRC2002-05-02
1488451734498703K010007ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAPGCJ2001-02-22
1469001957578813K000515PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,MQV2000-09-15
1469001061302213DEN160032Accelerate Pheno system, Accelerate Phenotest BC KitPRH2017-02-23
1469171379420059DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mmPOL2016-09-02
1469001968028675BK860040
1469001902867936BK860028

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE172013-08-07
DQY92018-10-05
KKX82010-11-09
DWF72013-03-22
MQV62007-04-18
GCJ42014-02-19
OOE42010-10-18
QBP32014-12-04
NAY32014-07-25
DYB32014-03-06
NEU32013-06-27
FYA32010-12-23
KNW32010-04-29
GAT22018-08-01
QEW22018-05-15
DXC22017-01-26
CAZ22012-08-02
BTR22012-05-11
FPA22012-05-04
JCT22007-09-19
NRY12018-06-20
GXI12017-08-09
PRH12017-02-23
PNG12016-11-03
DWM12016-10-31
POL12016-09-02
PHX12016-08-25
MBI12016-08-03
DQX12015-03-11
KWS12014-11-14
PGT12014-08-29
GEI12014-07-30
MCW12014-07-23
LWS12012-09-28
HQC12012-09-06
OFC12010-03-26
HCG12009-09-30
DQR12008-01-31
FOZ12007-11-09
LFD12006-10-27