FDA.reportPublic FDA data

Sterigenics U.S., LLC

Matched from indexed company URL: 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
10548111000114185Sterigenics U.S. LLC1N2026-01-01502 Prairie Mine Rd MULBERRY FL US 33860
10585841000219637Sterigenics US LLC1N2026-01-0110811 Withers Cove Park Drive Charlotte NC US 28278
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
14236623000215273Sterigenics US LLC1N2026-01-011003 Lakeside Drive Gurnee IL US 60031
16495183001236277Sterigenics US LLC1N2026-01-013125 Wichita Court Fort Worth TX US 76140
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
20111712011171Sterigenics US LLC1N2026-01-014900 Gifford Ave Los Angeles CA US 90058
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
29533593000215205Sterigenics U.S. LLC1N2026-01-012311 Lincoln Ave Hayward CA US 94545
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
1469001903635359P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS2012-09-28
1469231949820517P020014ESSURE SYSTEMHHS2002-11-04
1038471831049149P020012ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLERLMH2006-10-27
1038441305387897K993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1999-10-20
1469081264859005K990707MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERSDQY1999-03-22
1754951624084224K990671DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPEHOZ1999-05-10
1038441549050430K982894MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1998-09-11
1469081356020224K981198MEDTRONIC ZUMA GUIDING CATHETERDQY1998-08-07
1467871509636781K962907SKINNY,FRANSEEN,WESCOTT NEEDLESKNW1996-10-23
1038431475684294K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
1469171575218025K960248GENERAL PROCEDURE KITFMF1996-04-12
1469001250393281K953939QUINTESTSCL1995-11-13
1469171550205863K945484PIDURAL STEROID SYSTEMCAZ1995-06-02
1469071152548613K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
1038431753360744K932553DISPOSABLE SUTURE PLACEMENT SYSTEMGCJ1994-05-12
1469071821535253K925416SYMBIOSIS BONE MARROW BIOPSY NEEDLEGAA1993-02-23
1040911821535253K925416SYMBIOSIS BONE MARROW BIOPSY NEEDLEGAA1993-02-23
1038471899027654K911109OPHTA SIL (R), LACHRYMAL INTUBATION SETSOKS1991-05-01
1469081067383154K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDUDTR1990-04-20
1469172011091690K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)DXT1989-04-18
1040911721014269K881787ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIREDQX1988-07-25
1038451302435559K881767VIGGO INSUFLONFOZ1988-08-24
1040911089358650K851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLOKNT1985-06-12
1469001089358650K851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLOKNT1985-06-12
1038431195778969K800823QUICK FILLDXT1980-04-29
1469171033676125K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)GAT2018-08-01
1038471283940713K181591Fixated Asfora BULLET CAGE® (FABC)MAX2018-09-26
1754951375024802K181578DemeTECH PTFE Nonabsorbable Surgical SutureNBY2018-10-11
1038431567954022K180986XableCath Support Catheter Product FamilyDQY2018-05-15
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
1469051622307997K173332OMNI Surgical SystemMRH2017-12-21
1469051333403217K171905VISCO 360 Viscosurgical SystemMRH2017-07-27
1469001122124148K170827INTRACEPT Intraosseous Nerve Ablation SystemGXI2017-08-09
1038431227345634K170041XableCath Support CatheterDQY2017-09-07
1469171852249263K163693IntraClude Intra-Aortic Occlusion DeviceDXC2017-01-26
1469051988970135K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgePEW2016-09-21
1469051434920096K162203POGO Automatic Blood Glucose Monitoring SystemNBW2017-04-06
1040911244848410K162097InTRAkitDYB2016-11-17
1040911562681748K162027TRAcelet Compression DeviceDXC2016-10-21
1040911651333214K161985Steerable Guide CatheterDRA2016-08-07
1038471787253281K161266Athena Breast PumpHGX2016-08-11
1469001367135230K161189Integra TITAN Reverse Shoulder SystemPHX2016-08-25
1469002007468113K161033AFX™ Femoral Implant With InserterMBI2016-08-03
1038451475598044K160846AmplifEYEFED2016-07-14
1467871433661147K160450Pleurx Pleural Catheter SystemDWM2016-10-31
1467871301231889K160437PleurX Peritoneal Catheter SystemPNG2016-11-03
1040911987161394K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMAV2016-04-13
1038471659641598K152574NavioOLO2015-10-20
1469051646637617K152493POGO Automatic Blood Glucose Monitoring SystemNBW2016-04-25
1038431681907139K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMUU2015-05-22
1469051055698987K150392PROPEL deviceDZJ2015-09-18
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
1488571418782165K143316Attain Hybrid Guide WireDQX2015-03-11
1469001510554206K142413TITAN Modular Total Shoulder SystemKWS2014-11-14
1040911998793783K142199Ascendra Balloon Aortic Valvaloplasty CatheterOZT2014-10-29
1469001562853336K141848IOGYN SYSTEMPGT2014-08-29
1469171763361919K141484OPEN FMSEALERGEI2014-07-30
1038441616704575K141110CRYOCARE CS SURGICAL SYSTEMGEH2015-06-25
1469171916763993K140775TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEMMCW2014-07-23
1469001575095871K140657CUROS RED PORT PROTECTORQBP2014-12-04
1488451635294360K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
1040911544069185K133983INTRA. OX HANDHELD TISSUE OXIMETERMUD2014-09-12
1488451676421904K1338458MM TROCAR KITGCJ2014-02-19
1469051964046825K133281NEOTRACT UROLIFT SYSTEMPEW2013-12-20
1040911810050966K133203SINGLE-SITE PORTGCJ2014-05-09
1469081496794882K133026UNBALLOON NON-OCCLUSION MODELING CATHETERDQY2013-12-31
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
1469281209095526K131654STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERNEU2013-06-27
1469171235958801K131627CATHETER INTRODUCER SHEATHDYB2014-03-06
1469001811435414K131345TIARRAY DENTAL IMPLANT SYSTEMDZE2013-08-07
1040911775361467K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
1469001426055964K130124CATALYST II AND IIIDXC2013-03-14
1469051426055964K130124CATALYST II AND IIIDXC2013-03-14
1469051927986776K130041SHEATHES STERILE ULTRASOUND GELMUI2013-02-06
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
1038441152908680K123120LENSX LASER SYSTEMOOE2012-12-12
1038451228764431K122686ACCU-CHEK ULTRAFLEX INFUSION SETFPA2012-11-16
1040911746613440K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESNAY2013-07-30
1469171597219013K122190PRELUDE 7F SHORT SHEATH INTRODUCERDYB2012-08-17
1469081160669935K121839UNBALLOON NON-OCCLUSIVE MODELING CATHETERDQY2012-08-08
1469051358308196K121713PMT BONE SCREWSHWC2012-09-27
1038441535011942K121555CENTURION VISION SYSTEMHQC2012-12-21
1469081355210852K121525PERIFUSE CATHETERCAZ2012-08-02
1038441466626225K121390LUBE JELLY SURINGEKMJ2012-08-10
1040911528973297K121234GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATINGDYB2012-11-20
1469001786648396K121171CUROS TIPQBP2012-11-26
1469171056791156K120964UPSTREAM GR CATHETERDQY2012-05-25
1038471217399821K120906ZIMMER TRABECULAR METAL TOTAL ANKLEHSN2012-08-24
1469171651025018K120780EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICEDWF2012-06-27
1469001009473986K120732LENSSX LASER SYSTEMHQC2012-09-06
1469171331966163K120548HLIC NEEDLE-LESS VALVEFPA2012-05-04
1040911926199708K120428GORE DRYSEAL SHEATHDYB2012-04-20
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
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
1469171005419720K112887UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTORDYB2012-03-21
1469001771166446K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
1040911771166446K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
1488451060109113K111992CUROS PORT PROTECTORQBP2012-01-12
1040911544936905K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
1040911452181969K103500GORE EMBOLIC FILTERNTE2011-05-23
1467871108421637K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSFYA2010-12-23
1469251108421637K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSFYA2010-12-23
1469071108421637K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSFYA2010-12-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE172013-08-07
DQY112018-10-05
GEI102014-07-30
KKX102010-11-09
NAY72014-07-25
DWF72013-03-22
DYB62016-11-17
GCJ62014-05-09
HWC62012-09-27
MQV62007-04-18
OOE52012-12-12
KNT52004-12-10
DXC42017-01-26
MBI42016-08-03
FPA42013-10-08
FYA42010-12-23
KNW42010-04-29
MAX32018-09-26
QBP32014-12-04
NEU32013-06-27
DXT32011-12-15
GAT22018-08-01
QEW22018-05-15
MRH22017-12-21
NBW22017-04-06
PEW22016-09-21
DRA22016-08-07
DQX22015-03-11
KDI22014-02-04
OVE22014-01-16
HQC22012-12-21
CAZ22012-08-02
BTR22012-05-11
FOZ22007-11-09
FMF22007-09-21
JCT22007-09-19
GAA21993-02-23
NBY12018-10-11
NRY12018-06-20
GXI12017-08-09