FDA.reportPublic FDA data

Sterigenics US, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15265341526534Sterigenics US, LLC1N2026-01-01305 Enterprise Dr Lewis Center OH US 43035

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
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
1178471217833418K930831MG II POROUS KNEE SYSTEM FEMORAL COMPONENTSJWH1993-11-16
1178471364783794K922071ZIMMER ANATOMIC HIP SYSTEMLPH1994-02-22
1178472070901083K913649MODULAR CALCAR REPLACEMENTJDI1991-11-13
1178471499040684K911572MG II POROUS COBAL T-CHROME FEMORAL COMPONENTJWH1991-07-01
1178471661905114K883665COONRAD III TOTAL ELBOWJDC1989-02-03
1178471792159478K882494ELAN-E DISPOSALBE DRAPEKKX1988-07-08
1178471646127478K872019BI-ARTICULAR II HIP DEVICEKWY1987-07-21
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
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
1178471266634436K133476SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTIONHJO2014-02-12
1178471076405495K122529ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACEHSX2012-11-16
1178471690959774K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEDXT2011-12-15
1178471345909699K081768COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLESNAJ2008-12-23
1178471582639860K073515TRANS1 FACET SCREWMRW2008-03-11
1178471774851313K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESJDL2008-08-07
1178471160684493K052321VERSYS EPOCH FULLCOAT HIP PROSTHESISLPH2006-02-15
1178471028610430K042761WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIESKTT2004-11-17
1178471324655960K040186ANSPACH MRI SAFE SURGICAL DRILL SYSTEMHBB2004-04-15
1178471609951454K030733MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIESLPH2003-05-01
1178471931699748BK850026
1178471111574510
1178471461036877
1178471480390581
1178471003555418
1178471003594508
1178471005456165
1178471005680527
1178471005828820
1178471008003128
1178471008527206
1178471010358970
1178471013115493
1178471013300708
1178471015461480
1178471017772303
1178471017813032
1178471018303577
1178471018310048
1178471018756881
1178471020924905
1178471021871601
1178471022782230
1178471024783855
1178471024873982
1178471027388147
1178471027554307
1178471029523934
1178471029718598
1178471031270518
1178471033716528
1178471034035377
1178471034110964
1178471035232662
1178471035393223
1178471037157078
1178471037797415
1178471039716256
1178471042619503
1178471042734418
1178471045810253
1178471046059068
1178471047510196
1178471047814066
1178471048385187
1178471049456132
1178471053858583
1178471054793991
1178471057393160
1178471057827828
1178471058125506
1178471060188226
1178471060662980
1178471061078210
1178471062809112
1178471064416625
1178471065320910
1178471065795441
1178471066025801
1178471068075083
1178471068082407
1178471072622668
1178471072861154
1178471074826866
1178471075301222
1178471076097022
1178471077722924
1178471078060950
1178471078421126
1178471081303350
1178471082765351
1178471086970463
1178471087255883
1178471087321023
1178471088973623
1178471089112470
1178471089450252
1178471092186073
1178471092835212
1178471093621972
1178471094110877
1178471096159718

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH71999-05-05
JDI71997-01-09
LPH52019-11-05
KTT22004-11-17
KWY21987-07-21
HJO12014-02-12
HSX12012-11-16
DXT12011-12-15
NAJ12008-12-23
JDL12008-08-07
MRW12008-03-11
HBB12004-04-15
MKO11998-01-21
LWJ11996-10-08
JDQ11994-04-19
JDC11989-02-03
KKX11988-07-08
KWL11981-08-12
JDS11980-02-19
KWT11979-06-22