FDA.reportPublic FDA data

ISOMEDIX OPERATIONS INC.

Matched from indexed company URL: Isomedix Operations, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10478431047843ISOMEDIX OPERATIONS INC.1N2026-01-012072 Southport Rd SPARTANBURG SC US 29306
12204771220477ISOMEDIX OPERATIONS INC.1N2026-01-01435 WHITNEY ST. Northborough MA US 01532
13196601000136478ISOMEDIX OPERATIONS INC.1N2026-01-0123 ELIZABETH DR. CHESTER NY US 10918
14242633003015552Isomedix Operations, Inc.1N2026-01-012500 Commerce Dr Libertyville IL US 60048
14506621450662Isomedix Operations, Inc.1N2026-01-011880 Industrial Dr Libertyville IL US 60048
15267111526711ISOMEDIX OPERATIONS INC1N2026-01-014405 MARKETING PLACE GROVEPORT OH US 43125
16438171643817ISOMEDIX OPERATIONS INC1N2026-01-011435 ISOMEDIX PLACE EL PASO TX US 79936
16509073002681132Isomedix Operations Inc.1N2026-01-011175 Isuzu Pkwy GRAND PRAIRIE TX US 75050
17209291720929ISOMEDIX OPERATIONS INC.1N2026-01-019120 SOUTH 150 EAST Sandy UT US 84070
20306243000206435Isomedix Operations, Inc.1N2026-01-0143425 Business Park Dr Temecula CA US 92590
20320983003058448Isomedix Operations, Inc1N2026-01-011000 Sarah Pl ONTARIO CA US 91761
20321123003076831Isomedix Operations Inc.1N2026-01-017685 ST.ANDREWS AVE. SAN DIEGO CA US 92154
21837442183744Isomedix Operations, Inc.1N2026-01-01380 90TH AVE NW Minneapolis MN US 55433
22453042245304ISOMEDIX OPERATIONS INC.1N2026-01-019 Apollo Dr WHIPPANY NJ US 07981
22465522246552Isomedix Operations Inc.1N2026-01-013459 SOUTH CLINTON AVE. S Plainfield NJ US 07080
30098883443009888344Isomedix Operations Inc1N2026-01-011441 Don Haskins Dr El Paso TX US 79936
30138205013013820501Isomedix Operations Inc.1N2026-01-012 Nucifora Blvd Chester NY US 10918

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
30051102041546P980031INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTSLQE1999-04-09
29981782696544P960024
30051096677103P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB1999-05-04
30091690048716P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATIONMAX1996-10-29
30051090575799P950002BAK INTERBODY FUSION SYSTEMMAX1996-09-20
30051039464221P930038Angio Seal Vascular Closure DeviceMGB1996-09-30
30091646256838P900023ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEMDSQ1992-11-20
29981510808774P880079
30051587007464P870076FALOPE RING BAND AND APPLICATOR SYSTEMSKNH1993-09-29
240061221784342P860047HYDROXYPROPYLMETHYLCELLULOSE 20MG/MLLZP1988-07-12
29981599784735P850055
30151191843395P850045
30151113155575P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
29981526483575P820040
30151084395294P810040SUPERSTATLMF1982-01-29
30161084395294P810040SUPERSTATLMF1982-01-29
30051955623856P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
30081955623856P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
240061595248018P160048EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEMQCD2018-06-21
30151234164580P150022CLOSER VASCULAR SEALING SYSTEMMGB2016-02-12
30101234164580P150022CLOSER VASCULAR SEALING SYSTEMMGB2016-02-12
30051740284584P130026TACTICATH QUARTZ SETOAE2014-10-24
30052056057772P130024LUTONIX DRUG COATED BALLOON PTA CATETERONU2014-10-09
30091212086622P130004RESURE SEALANTPFZ2014-01-08
30051106037758P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
30081229609299P120002SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMSNIP2012-11-07
30052018586505P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
240041244294813P100012NUVASIVE PCM CERVICAL DISC SYSTEMMJO2012-10-26
30091572542025P050044VITAGEL RT3 SUTGICAL HEMOSTATPMX2006-06-16
30101572542025P050044VITAGEL RT3 SUTGICAL HEMOSTATPMX2006-06-16
30082012789368P050043FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCHMGB2007-08-20
30121746949917P050039NOVATION CERAMIC ARTICULATION HIP SYSTEMMRA2007-07-05
30121679883136P050038ARISTA AH ABSORBABLE HEMOSTATLMG2006-09-26
30111941671719P040051STELKAST SURPASS ACETABULAR SYSTEMMRA2006-05-12
30051844953192P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
30081999469900P030047CORDIS PRECISE NITINOL STENT SYSTEMNIM2006-09-22
30051495150166P030045INTRASTENT DOUBLESTRUT STENTNIO2004-06-08
30091006387762P020049PROCOL VASCULAR BIOPROSTHESISLXA2003-07-29
30121006387762P020049PROCOL VASCULAR BIOPROSTHESISLXA2003-07-29
30081344711678P020036S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEMNIO2003-08-12
30051444979019P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD2003-08-25
30051909816480P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
30051593628620P010047PROGEL PLEURAL AIR LEAK SEALANTNBE2010-01-14
30052056490075P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
30131102450611P000035TMJ FOSSA-EMINENCE PROSTHESIS(TM)MPI2001-02-27
30051838299154P000033INTRA COIL SELF-EXPANDING PERIPHERAL STENTNIP2002-04-03
30131622007547P000023TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESESLZD2001-01-05
240041371881133K994306REVERSOKOC2000-03-20
30051184446221K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEMLJT2000-01-27
30161389727794K994205MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE2000-02-29
30051439168832K994097MEDAMICUS EPIDURAL INTRODUCERGZB2000-03-01
30081977497280K994068S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE1999-12-23
30091790023455K993801GYNECARE LAPAROSCOPIC MORCELLATORHET2000-02-07
30081089991242K993720CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETERKNQ2000-01-18
30091052781954K993699THE STRIPPERMQH2000-05-16
30161995271971K993650URETERAL ACCESS SHEATH SET - NEW MODELSFED1999-12-28
30121787276433K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
30081474661076K993646S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE1999-11-28
30152000523102K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXHAW2000-01-18
30122000523102K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXHAW2000-01-18
30132000523102K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXHAW2000-01-18
30161540005623K993148STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGAFYA1999-10-15
30161292289836K993135IMPLANTABLE CLIP FOR GENERAL SURGERYFZP1999-12-01
30051099076879K992816MODIFICATION TO INTRASTENTFGE1999-10-15
30091661872919K992776UNI-GRAFT K DV PATCHDXZ1999-11-16
240041170727853K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1999-10-18
30091873359977K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1999-10-18
30061434302276K992673VISTA BRITE TIP CATHETERSDQY1999-10-12
30081434302276K992673VISTA BRITE TIP CATHETERSDQY1999-10-12
30151121113778K992617HEX BUTTONHTN1999-10-27
30081793950598K992494FLEXIFLO ENTERAL FEEDING TUBEKNT1999-08-25
30091962639630K992443ADVANTA GRAFTDSY1999-08-20
30091457839991K992441ADVANTA GRAFTDYF1999-08-20
240061415994559K992416PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATELYC1999-10-15
30091461613590K992396BIORCI SCREWHWC2000-01-12
30121273410379K992367EBI XFIX DYNAFIX SYSTEM HA COATED SCREWSHWC1999-09-23
2104321263457994K992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINFRO1999-08-12
30061567785465K992347CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSDQO1999-10-08
30081567785465K992347CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSDQO1999-10-08
30091028116681K992218DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601GEI1999-07-30
30081419926803K992137UROLOGICAL CATHETERGBM1999-09-03
30141104121458K992083SCATTERFREE LATERAL EMITTING FIBERGEX1999-07-12
30151265943607K992065GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEADKWS1999-07-12
30151653936677K9919473I CERAMIC ABUTMENT SYSTEMDZE1999-09-29
30121653936677K9919473I CERAMIC ABUTMENT SYSTEMDZE1999-09-29
30101653936677K9919473I CERAMIC ABUTMENT SYSTEMDZE1999-09-29
240061507103266K991897CATHETER INNOVATIONS IMPLANTABLE PORTLJT1999-10-21
240062018335337K991879SPRING-WOUND EPIDURAL CATHETERBSO1999-10-28
30091006621061K991813UNI-GRAFT K DV VASCULAR GRAFTDSY1999-06-01
240051699633854K991759MAERSK MEDICAL CONTOUR INFUSION SETFPA1999-06-25
30061046060761K991673CORDIS TEMPO ANGIOGRAPHY CATHETERDQO1999-05-26
30081046060761K991673CORDIS TEMPO ANGIOGRAPHY CATHETERDQO1999-05-26
30111094724310K99162226 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINERJDI1999-07-14
29982013694999K991403SOLO-CARE BRAND MULTI-PURPOSE SOLUTIONLPN1999-07-16
30121807832474K991294MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEMKZE1999-04-23
30081498708420K991253FALCON IVF ROUND DISHMQK1999-05-05
30081931462863K991251FALCON IVF ONE WELL DISHMQK1999-05-05
30081151116070K991249FALCON IVF FOUR WELL PLATEMQK1999-05-05
30141264491160K991219C-FLEX URETERAL STENTSFAD1999-06-21
30162031302826K991114REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE1999-07-14
30081616957648K991090PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)ITI1999-09-24
30081628580885K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
30082051847522K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKA1999-05-28
30091757805332K990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1999-02-18
30101757805332K990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1999-02-18
30121777124076K990197MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEMMEH1999-02-04
29981322826440K990180BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSINGMGQ1999-08-13
30101322826440K990180BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSINGMGQ1999-08-13
240061425627780K990042SILON DUAL-DRESSFRO1999-03-19
30151886754532K984541GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEADKWT1999-01-14
30081322644512K984500CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1998-12-23
30161565998991K984287PROVISIONAL DENTAL IMPLANT SYSTEMDZE1999-03-01
30091884701895K983870OSTEONICS RESTORATION HA HIP STEMSMEH1998-12-02
30101884701895K983870OSTEONICS RESTORATION HA HIP STEMSMEH1998-12-02
240061792457390K983794CHEMO MINI SPIKE PLUSLHI1999-03-23
30121633548407K983491DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINERLPH1998-12-02
30091911814765K983276HYDROFERA BACTERISTATIC NASAL DRESSINGEMX1999-09-14
30131120659402K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTDRO1999-09-15
30131180016710K983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)DRO1999-09-15
240041336933889K983076MEDISYSTEMS TRANSDUCER PROTECTORFIB1998-11-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE1162015-11-20
FPA1002017-11-07
DYB652019-08-01
JWH612018-10-25
FGE512011-06-08
GEI472018-11-14
DQY412017-06-07
DQO332007-04-16
LPH322013-09-19
MQV312017-05-02
GCJ302014-12-23
JDI272009-12-17
CAC232012-10-25
MEH232009-10-20
LJT222016-06-06
HWC222015-10-15
MAX202017-10-23
MBI202015-02-23
FRN202012-03-05
NHA202012-01-23
QEZ192018-09-11
FTL192015-10-22
FMF182015-01-08
KWQ182012-01-17
GEX172017-06-08
DSY172013-03-07
LHI152015-12-04
LRC152015-11-20
NLQ142019-08-15
FMI142014-07-22
DQX132015-01-15
QSY132012-11-15
LJS122015-03-31
FRO122012-07-09
OVE112017-06-28
NUJ112016-09-20
DRF112016-05-06
LYC112010-12-21
LZO112008-02-21
EMX111999-09-14

PMN#