FDA.reportPublic FDA data

Sterigenics U.S. LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10548111000114185Sterigenics U.S. LLC1N2026-01-01502 Prairie Mine Rd MULBERRY FL US 33860
29533593000215205Sterigenics U.S. LLC1N2026-01-012311 Lincoln Ave Hayward CA US 94545

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1754951624084224K990671DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPEHOZ1999-05-10
1754951375024802K181578DemeTECH PTFE Nonabsorbable Surgical SutureNBY2018-10-11
1469051622307997K173332OMNI Surgical SystemMRH2017-12-21
1469051333403217K171905VISCO 360 Viscosurgical SystemMRH2017-07-27
1469051988970135K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgePEW2016-09-21
1469051434920096K162203POGO Automatic Blood Glucose Monitoring SystemNBW2017-04-06
1469051646637617K152493POGO Automatic Blood Glucose Monitoring SystemNBW2016-04-25
1469051055698987K150392PROPEL deviceDZJ2015-09-18
1469051964046825K133281NEOTRACT UROLIFT SYSTEMPEW2013-12-20
1469051426055964K130124CATALYST II AND IIIDXC2013-03-14
1469051927986776K130041SHEATHES STERILE ULTRASOUND GELMUI2013-02-06
1469051358308196K121713PMT BONE SCREWSHWC2012-09-27
1469051222376813
1754951000238235
1754951000882228
1469051002320969
1754951004528661
1469051009160237
1469051012901309
1754951020007738
1754951025350538
1469051028058194
1754951028064722
1754951030323656
1754951034444251
1754951037157078
1469051037157078
1754951037658001
1469051038267479
1754951038688924
1469051051950278
1469051053858583
1469051059470124
1469051060622303
1469051063681047
1754951067701143
1754951072622668
1754951074826866
1754951079891474
1469051082609893
1754951086797957
1754951089112470
1754951095250486
1754951096226438
1469051098104025
1754951098104025
1754951102612745
1469051104458398
1469051108898999
1469051112105792
1469051117454084
1754951122949037
1754951131310451
1469051132012669
1754951137148936
1469051137262786
1754951137278992
1754951141474835
1754951141980864
1754951142201432
1469051145407589
1754951147445279
1469051148143718
1754951149829375
1469051154607562
1469051157018483
1469051157732679
1469051164967424
1469051165901072
1754951166663669
1469051167213745
1469051167326648
1754951169182521
1754951170267378
1754951171706697
1754951174565875
1469051174813136
1469051176271313
1469051178769473
1754951178769473
1754951180270271
1754951180309257
1754951183012352
1754951190401287
1754951193691075
1754951198251109
1469051200065295
1469051202885182
1469051210557838
1469051218878581
1754951220371677
1469051225892525
1754951225942264
1754951225943774
1469051226363734
1754951226622099
1754951229126772
1469051229132786
1754951230169183
1754951230368565
1469051232503024
1469051233639383
1469051234873925
1754951238022183
1754951243227092
1754951244642388
1469051246481470
1754951246568561
1469051247187974
1754951248597453
1754951254401395
1754951257992283
1469051260083974
1754951260550248
1469051260565000
1754951266164576
1754951267403882
1469051267473534
1754951268833276
1469051274162622

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MRH22017-12-21
NBW22017-04-06
PEW22016-09-21
NBY12018-10-11
DZJ12015-09-18
DXC12013-03-14
MUI12013-02-06
HWC12012-09-27
HOZ11999-05-10