FDA.reportPublic FDA data

ISOMEDIX OPERATIONS INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15267111526711ISOMEDIX OPERATIONS INC1N2026-01-014405 MARKETING PLACE GROVEPORT OH US 43125
16438171643817ISOMEDIX OPERATIONS INC1N2026-01-011435 ISOMEDIX PLACE EL PASO TX US 79936
30098883443009888344Isomedix Operations Inc1N2026-01-011441 Don Haskins Dr El Paso TX US 79936

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
30111941671719P040051STELKAST SURPASS ACETABULAR SYSTEMMRA2006-05-12
30061434302276K992673VISTA BRITE TIP CATHETERSDQY1999-10-12
30061567785465K992347CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSDQO1999-10-08
30061046060761K991673CORDIS TEMPO ANGIOGRAPHY CATHETERDQO1999-05-26
30111094724310K99162226 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINERJDI1999-07-14
30111352218257K981451ARGOMEDICAL BIPOLAR SYSTEMKWL1998-08-21
30111894247761K980276STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEMJWH1998-04-24
30061502130238K973401TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)DQO1997-11-18
30061770848876K9716464F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETERDQO1997-07-14
30111736130728K970714STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)CAC1997-12-16
30061837640759K970631PUNCTUAL OCCLUDERLZU1997-04-23
30111702059551K970490PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENTLZO1997-05-02
30111419060995K970194PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENTJDI1997-04-14
30061353747850K9627594F NYLEX ANGIOGRAPHIC CATHETERDQO1996-10-10
30061219951035K961863PARACENTESIS TRAYSLRO1996-05-28
30061987835809K9609751-4F INFINITI ANGIOGRAPHIC CATHETERDQO1996-04-02
30111922853882K960908SRRS PRESSED FIT FEMORAL REVISION COMPONENTLWJ1996-08-08
30061358420393K960868B.A.S.I.C. DENTAL IMPLANT SYSTEMDZE1996-11-14
30111167229584K960810BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MMHET1996-10-21
30111246630508K96018022 MM COCR HEAD & POLYETHLENE LINERLPH1996-05-02
30061968151004K955749TEX-CARE STERILE STOCKINETTEKKX1996-11-22
30111637702551K954466PROFORM POROUS BEADED FEMORAL STEMLPH1995-12-04
30112003852193K954265TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLEKNW1995-09-29
30111618866181K953268DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENTLWJ1996-01-17
30112010535275K953169STELKAST ALL POLYETHYLENE ACETABULAR CUPLZO1995-08-08
30111078262961K952461ENDO PROSTHESIS FEMORAL HEADJDI1995-06-30
30111638290112K951083PROFORM CEMENTED FEMORAL COMPONENTJDG1995-05-22
30111700596447K950827PROFORM POROUS ACETABULAR ASSEMBLYLPH1995-04-18
30111136581595K946371PROVIDENT HP SYSTEMJDI1995-04-05
30111960141583K945146CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLEFCG1994-12-21
30111801728122K945124BREAST LESION LOCALIZATION NEEDLEGDF1994-11-22
30061104341549K942094CORDIS SAVVY PTA BALLOON CATHETERLIT1994-11-01
30062041121313K940431TECNADYNE 20/20 FOG INHIBITOR KITGCJ1994-04-29
30111969589977K936256MODULAR CERAMIC FEMORAL HEADLZO1994-11-14
30111289440643K935484PROVIDENT HIP SYSTEMLPH1994-06-06
30111273355761K934162PROFORM HA HIP SYSTEMJDO1994-03-09
30111435664915K934161PROFORM HIP SYSTEMJDO1994-03-10
30111838769230K931215HAND-TROL SDWG1994-03-28
30061838769230K931215HAND-TROL SDWG1994-03-28
30061831432520K930479NYLEX CATHETERSDQO1993-04-21
30061807480292K923672COX DISPOSABLE ENDOSCOPE CLEANING BRUSHFEB1992-09-23
30061087067820K923645VISITEC ASPIRATING SYRINGEFMF1992-09-30
30061425186350K923516COMPOUND BENZOIN TINCTURE USP SEPPKMF1994-01-25
30061232423531K923487BAL CATHKTR1993-07-30
30061975644519K915836CORDIS 5.0 FRENCH SUPER TORQUE CATHETERSDQO1992-02-11
30061292728742K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERSLYU1991-12-02
30061907142738K910941LIFELINER SURGICAL GLOVEFYE1991-05-09
30112010335127K901949IV SETFPA1990-09-12
30061942387882K900310REPEL SURGICAL GLOVE LINERSLYU1990-03-01
30112015161811K893992NOETIX, BIOPSY NEEDLEKNW1989-09-08
30111081832676K893409YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMPBZT1989-07-20
30111346607260K891315ATTENUATING SURGICAL GLOVELZC1989-10-05
30111869016449K883793DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)FLL1988-11-21
30061368772455K882302IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080FPA1988-07-12
30111765441881K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-ClipPZX2019-08-21
30111017395158K180138AtriCure cryoICE cryo-ablation probe (CRYO2)GXH2018-02-15
30111263904944K142097SELEC-3 I.V.ADMINISTRATION SETFPA2014-08-29
30111989156235K140402MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SETLHI2014-04-03
30111339039902K122773CROSS-OVER ACETABULAR SHELL & LINEROQG2012-10-09
30061067603751K1221986.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEMDZE2013-04-05
30111745487009K120156PUREIMAGE ULTRASOUND TRANSMISSION GELITX2012-02-08
30061734673108K112562BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETEROYI2011-12-15
30111776158279K111765FULL CORE BIOPSY SYSTEMKNW2011-09-06
30111448084790K111034AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGENGT2011-07-14
30111218516159K110518IBAGKNX2011-06-24
30061771422887K110337UNIVERSAL MAXILLARY MOLARDZE2012-03-16
30061320536935K1014683M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLEFYA2011-04-14
30111907437129K094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMOQG2011-03-24
30061042472323K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000HOZ2009-10-23
30061539547876K090938FLOW CONTROLLERLZU2009-06-04
30111835352931K081458PROVEN STEM EXTENDERJWH2008-06-06
30112010373722K063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTJWH2007-01-18
30061872279585K062000HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCHLFL2006-09-25
30061940208279K061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSFPA2006-07-26
30061076692321K060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXFGE2006-04-27
30061892078302K060245HARMONIC SCALPEL BLADES AND SHEARSLFL2006-04-07
30111041605679K051976PROVEN REVISION MODULAR TIBIAL TRAYJWH2005-10-17
30062016541543K041796PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2004-08-03
30112059939669K041060E-Z LUBRICATING JELLYKMJ2004-05-07
30111834128717K033944STELKAST 32MM MODULAR CERAMIC FEMORAL HEADLZO2004-03-12
30111187611833K032824STELKAST UNICONDYLAR KNEE SYSTEMHSX2003-11-13
30061908772741K032457MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-09-04
30061617235280K032137PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-09-17
30111454414391K032110PROCLASS PRESS FIT HIP STEMLWJ2003-09-22
30111432032819K031901PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERTJWH2003-10-10
30061053111423K031287STERI-DRAPE SURGICAL DRAPESKKX2003-09-10
30061141529448K031197MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-06-16
30111298885189K030577PROVEN MODULAR TIBIAL TRAYJWH2003-03-25
30061554658420K030409SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEMFGE2003-03-10
30111194061760K024372CP MEDICAL BONE WAXMTJ2003-06-19
30061455886995K023217MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-10-25
30111682422440K022634CO-AXIAL INTRODUCER NEEDLEDYB2002-11-06
30111263353284K021908PROVEN MODULAR POSTERIOR STABILIZED FEMORALJWH2002-07-09
30061964508889K021898SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-08-14
30061265744533K020052SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-02-11
30111720853894K011270AUTOMATED CORE BIOPSY DEVICEFCG2001-06-22
30061753157840K010445PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEMFGE2001-03-16
30111180806960K010282LATERAL OFFSET PROTRACT PRESS FIT HIP STEMLPH2001-02-09
30111179320733K010241PROTRACT PRESS FIT HIP STEM-HA COATEDLPH2001-02-08
30061905448093K003964TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306BDTK2001-01-19
30111310270640K003447PROTRACT PRESS FIT HIP STEMLPH2000-12-15
30061083403129K003365S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)FGE2000-11-22
30061820702459K003336MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2000-11-22
30061390889095K003190EN BLOC BIOPSY SYSTEMGEI2001-06-11
30111708021457K002796MODIFICATION TO PROVIDENT HIP SYSTEMLWJ2000-09-28
30111068797684K002281STELKAST PROVEN KNEE SYSTEMJWH2000-08-17
30111688979486K001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTJDG2000-09-27
30061908074242K001843S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2000-07-18
30111308348040K001745MODIFICATION TO PROVIDENT HIP SYSTEMLWJ2000-07-27
30111958470493K001299PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USPGAL2000-06-23
30111558323029K001184SILK, NONABSORBABLE, SURGICAL SUTURES, USPGAP2000-06-23
30111385303969K000113PROVEN KNEE SYSTEMJWH2000-04-04
30061573653268K000062CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KITDTK2000-07-07
30111610350467BK950033
30111065113009BK020001
30061056750045
30061130217708
1470901130217708
30061137215465
1470901137215465

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGE132006-04-27
JWH92008-06-06
DQO81999-10-08
LPH72001-02-09
LWJ52003-09-22
FPA42014-08-29
LZO42004-03-12
JDI41999-07-14
DZE32013-04-05
KNW32011-09-06
OQG22012-10-09
LZU22009-06-04
LFL22006-09-25
KKX22003-09-10
FCG22001-06-22
DTK22001-01-19
JDG22000-09-27
DWG21994-03-28
JDO21994-03-10
LYU21991-12-02
PZX12019-08-21
GXH12018-02-15
LHI12014-04-03
ITX12012-02-08
OYI12011-12-15
NGT12011-07-14
KNX12011-06-24
FYA12011-04-14
HOZ12009-10-23
MRA 12006-05-12
KMJ12004-05-07
HSX12003-11-13
MTJ12003-06-19
DYB12002-11-06
GEI12001-06-11
GAL12000-06-23
GAP12000-06-23
DQY11999-10-12
KWL11998-08-21
CAC11997-12-16