FDA.reportPublic FDA data

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
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
20321123003076831Isomedix Operations Inc.1N2026-01-017685 ST.ANDREWS AVE. SAN DIEGO CA US 92154
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
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
29981782696544P960024
30091690048716P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATIONMAX1996-10-29
30091646256838P900023ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEMDSQ1992-11-20
29981510808774P880079
240061221784342P860047HYDROXYPROPYLMETHYLCELLULOSE 20MG/MLLZP1988-07-12
29981599784735P850055
29981526483575P820040
30081955623856P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
240061595248018P160048EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEMQCD2018-06-21
30101234164580P150022CLOSER VASCULAR SEALING SYSTEMMGB2016-02-12
30091212086622P130004RESURE SEALANTPFZ2014-01-08
30081229609299P120002SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMSNIP2012-11-07
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
30081999469900P030047CORDIS PRECISE NITINOL STENT SYSTEMNIM2006-09-22
30091006387762P020049PROCOL VASCULAR BIOPROSTHESISLXA2003-07-29
30081344711678P020036S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEMNIO2003-08-12
30131102450611P000035TMJ FOSSA-EMINENCE PROSTHESIS(TM)MPI2001-02-27
30131622007547P000023TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESESLZD2001-01-05
240041371881133K994306REVERSOKOC2000-03-20
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
30081474661076K993646S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE1999-11-28
30132000523102K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXHAW2000-01-18
30091661872919K992776UNI-GRAFT K DV PATCHDXZ1999-11-16
240041170727853K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1999-10-18
30091873359977K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1999-10-18
30081434302276K992673VISTA BRITE TIP CATHETERSDQY1999-10-12
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
2104321263457994K992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINFRO1999-08-12
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
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
30081046060761K991673CORDIS TEMPO ANGIOGRAPHY CATHETERDQO1999-05-26
29982013694999K991403SOLO-CARE BRAND MULTI-PURPOSE SOLUTIONLPN1999-07-16
30081498708420K991253FALCON IVF ROUND DISHMQK1999-05-05
30081931462863K991251FALCON IVF ONE WELL DISHMQK1999-05-05
30081151116070K991249FALCON IVF FOUR WELL PLATEMQK1999-05-05
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
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
30081322644512K984500CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1998-12-23
30101884701895K983870OSTEONICS RESTORATION HA HIP STEMSMEH1998-12-02
30091884701895K983870OSTEONICS RESTORATION HA HIP STEMSMEH1998-12-02
240061792457390K983794CHEMO MINI SPIKE PLUSLHI1999-03-23
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
30091973768512K983014SUMMIT ACETABULAR SYSTEMLPH1998-10-27
240061705775869K982888VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEMLJT1998-10-20
30101928350679K982032OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1998-07-09
30091928350679K982032OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1998-07-09
30081469184457K981922LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRIQPB1998-12-10
240041000857205K981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERDQO1998-08-18
240061031184614K980844SURGIDEV SILICONE PUNCTUM PLUGLZU1998-05-11
240061311387392K980566VAXESS PERIPHERALLY INSERTED CENTRAL CATHETERFOZ1998-09-14
240041941538212K974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERDQY1998-02-19
30101142326423K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEMJWH1998-02-27
30091142326423K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEMJWH1998-02-27
30081562371053K974448CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1998-02-06
30081502130238K973401TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)DQO1997-11-18
30131323620385K973346UNCOATED ELECTROSURGICAL ELECTRODEGEI1997-11-07
30131509045935K973139ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTORGCJ1997-11-13
30081835196716K972978VISTA BRITE TIP GUIDING CATHETERSDQY1997-10-21
240061012442399K972678MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETSFRN1997-10-07
30091344410548K972678MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETSFRN1997-10-07
30081565761783K972584STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1997-10-01
30091989353987K972523PUNCTUAL OCCLUDERLZU1997-09-09
30081395263239K972069STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACKFQH1997-07-29
240041235633521K971860MEDISYSTEMS DIALYSIS PRIMING SETSKOC1997-08-18
30091251377135K971854OSTEOLOCK ACETABULAR SHELL SYSTEMLPH1997-07-30
30101251377135K971854OSTEOLOCK ACETABULAR SHELL SYSTEMLPH1997-07-30
30081770848876K9716464F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETERDQO1997-07-14
240062071263196K971233SOFT TIP EPIDURAL CATHETER KITCAZ1997-10-17
240061554530060K971165INTRODUCER SHEATH AND DILATORLDF1997-07-23
30081684220807K9708545 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERDQO1997-09-30
30081135502067K970727MPORT FOLDABLE LENS PLACEMENT SYSTEMMSS1997-12-17
30091837640759K970631PUNCTUAL OCCLUDERLZU1997-04-23
30081354174608K970392CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEMDRE1997-04-24
240061215654855K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERJJE1997-04-08
30081515663475K965211VISTA BRITE TIP CATHETERSDQY1997-03-11
240061419600913K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.GAM1997-02-12
30131093448872K965054PENCILGEI1997-01-24
30091100061139K964614ULTRAFERA WOUND DRESSINGKMF1997-02-06
30091743521210K964352TORQUE DEVICEDQX1997-01-28
240061976108391K964352TORQUE DEVICEDQX1997-01-28
30091454800256K963796KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERSJWH1996-12-09
30101454800256K963796KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERSJWH1996-12-09
240061650237885K963336HARMAC THERMODILUTION CATHETERDYG1997-08-14
240061990322612K963335HARMAC BALLOON WEDGE PRESSURE CATHETERDQO1997-10-16
240061803047142K963074HARMAC QUADPOLAR MAPPING PACING CATHETERDRF1997-06-25
240061166110974K962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONLDF1997-10-15
30081484125929K962830VISTA BRITE TIP CATHETERSDQY1996-10-17
30081353747850K9627594F NYLEX ANGIOGRAPHIC CATHETERDQO1996-10-10
240061834043671K962696PERIFIX PEDIATRIC EPIDURAL KITCAZ1997-04-03
240062043910124K962494PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATELYC1996-09-20
30091196282668K962475ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1997-02-20
240041991871550K962475ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1997-02-20
240061645793287K962433MEADOX EXXCEL EPTFE VASCULAR GRAFTDSY1997-03-17
30101456984901K962343TOXO IGG ELISA TESTLGD1997-03-24
29981456984901K962343TOXO IGG ELISA TESTLGD1997-03-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA732017-11-07
JWH482018-10-25
DYB402017-09-11
FGE272011-06-08
GEI252010-11-01
DQO212007-04-16
CAC202012-10-25
MEH202009-10-20
FRN192012-03-05
DQY182015-01-14
DSY162012-08-17
FTL152015-10-22
LPH152013-09-19
MQV142017-05-02
FMF142015-01-08
HWC122015-10-15
LJS122015-03-31
MBI112015-02-23
DZE112014-01-08
GCJ112010-05-05
FMI112007-08-02
LJT102016-06-06
CAZ92012-01-24
KWQ92012-01-17
LYC92010-12-21
MBH82018-02-02
BSP82014-06-27
OVE82014-05-08
JOW82010-07-16
LHI82003-01-13
JDI82002-04-26
LIT72014-06-27
KNT72011-09-29
KRH72010-07-15
HQC72009-10-20
FRO72008-04-25
MQH72004-09-29
NLQ62017-02-23
MAX62015-07-09
DTK62014-03-07

PMN#