FDA.reportPublic FDA data

Isomedix Operations, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20320983003058448Isomedix Operations, Inc1N2026-01-011000 Sarah Pl ONTARIO CA US 91761

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
30161084395294P810040SUPERSTATLMF1982-01-29
30161389727794K994205MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE2000-02-29
30161995271971K993650URETERAL ACCESS SHEATH SET - NEW MODELSFED1999-12-28
30161540005623K993148STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGAFYA1999-10-15
30161292289836K993135IMPLANTABLE CLIP FOR GENERAL SURGERYFZP1999-12-01
30162031302826K991114REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE1999-07-14
30161565998991K984287PROVISIONAL DENTAL IMPLANT SYSTEMDZE1999-03-01
30161157450922K973465LATIS GRAFT CLEANING CATHETERDXE1998-02-19
30161256040865K970776LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENTDZE1997-05-27
30161548040688K970127EDOSSEOUS DENTAL IMPLANTDZE1997-06-23
30162039664391K964220REPLACE TITANIUM IMPLANT SYSTEMDZE1997-03-05
30161899542369K963359INSUFFLATION NEEDLEHET1996-09-24
30161220885000K962668AMR-ACV CLAMPSDXC1996-11-04
30161888914750K961511HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLZK1996-06-28
30161227586249K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
30161645627282K960288HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-03-28
30161407309962K960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMSDZE1996-02-08
30161197626236K9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSDZE1996-03-08
30161262357827K955593EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAYEMX1995-12-22
30161641472700K955372BALL ATTACHMENT SYSTEMDZE1996-01-23
30161159837781K954865RESTORE HA DENTAL IMPLANT SYSTEMDZE1996-01-11
30161904801796K954819RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEMDZE1996-01-11
30161132205003K954512RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-02-23
30161881152277K953101PARAGON IMPLANT SYSTEMDZE1995-12-21
30161512730927K951111RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)DZE1995-03-31
30161271063869K950624HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1995-08-30
30161300140874K950586AVD INTIMAX THROMBECTOMY CATHETERDXE1995-05-15
30161108824063K950578SCREW-VENT IMPLANTDZE1995-07-11
30161077656278K950492ATRAUMAX SURGICAL CLAMPDXC1995-05-08
30161215562375K950024EXPANDACELL NASAL PACK WITH AIRWAYEMX1995-02-17
30162039148756K945260E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILSGEI1994-11-09
30161435577179K944964BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEMDZE1995-02-28
30161582779421K944069RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1995-02-28
30161192782854K944068RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)DZE1995-02-02
30161272807199K943489DISPOSABLE SURGICAL TROCARGCJ1994-08-09
30161607951540K941554SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1994-07-22
30161382307512K940133THE EXPANDACELL EAR PACKLRD1994-05-23
30161700765085K935724THE EXPANDACELL SINUS PACKEMX1994-05-12
30161239097253K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
30161229126038K931895ENDOSCOPE ACCESSORYGCJ1993-09-07
30161037133592K931468RESTORE HEX CYLINDER ENDOSSEOUS SYSTEMDZE1994-07-12
30161627182059K925779BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTSNHA1993-04-20
30161041485068K925777BRANEMARK SYSTEM ESTHETICONE ABUTMENT COMPLETEDZE1993-04-14
30161774875697K923636TROCAR W/ BLUNT TIP OBTURATORHET1993-11-05
30162071898096K923484STERI-OSS TITANIUM SCREW SERIES IMPLANTDZE1993-12-13
30161285808647K915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEHQC1991-12-27
30161710870602K912524EXPANDACEL NASAL TAMPONS, MODIFICATIONEMX1991-08-15
30161836905617K912059PRE-ANGLED ABUTMENTSDZE1992-02-11
30161985220656K911181INTIMAX(TM) IRRIGATION CATHETERGCA1991-04-18
30161238339595K910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERFGE1991-03-28
30161791959661K910372INTIMAX THROMBECTOMY CATHETERDXE1991-04-26
30162063353673K910006AVD INTIMAX (TM) BILIARY CATHETERFGE1991-02-13
30161342427915K905434ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102DZE1992-08-27
30162068250725K902969SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTSDZE1990-12-17
30161273245434K902256IRRIGATION CATHETER 4, 6 AND 10 FRENCHDQY1991-02-15
30161027008567K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIPDXC1990-07-06
30161341226397K901627ARTERIAL EMBOLECTOMY CATHETERDXE1990-10-19
30161405965751K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDEDXC1990-06-12
30161844418453K900179SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTSDZE1991-02-20
30161942891770K900171EXPANDACEL NASAL TAMPONSEMX1990-06-14
30161712401160K895691VASCULAR CLAMPDXC1989-12-13
30162026255585K894842IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADMFPA1989-09-12
30162072771487K883909SURGICAL SPRING CLIPSDSS1988-12-27
30161275048823K883790SURGICAL CLAMP INSERTSDXC1988-12-27
30161335500993K883717BIO-VENTDZE1989-09-01
30161386050700K874480MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)NAD1988-02-22
30161898918922K861182TIMELINE VENIPUNCTURE SYSTEMFPA1986-06-04
30161804661765K811101HYDROXYLAPATITELYC1981-11-20
30162041325262K791774LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRANKPE1979-10-26
30161913407894K791752LECTROVAC, VALLEYLAB MODELSGEI1979-10-04
30161988028651K791053THE DENVER SPLINTEPP1979-08-16
30161938951451K790582INTRAVASCULAR ADMINISTRATION SETFPA1979-05-29
30161847099091K183206Dexcom G6 Continuous Glucose Monitoring SystemQBJ2019-02-14
30161187104417K182653Voyant Maryland Fusion DeviceGEI2018-11-14
30162067597649K182405Dexcom Pro Q Continuous Glucose Monitoring SystemQDL2018-11-02
30161094134135K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemQDK2018-10-26
30161823754149K180699Voyant Open Fusion DeviceGEI2018-04-13
30162017814033K172624Voyant 5mm Fusion DeviceGEI2018-02-13
30161072148910K153017Voyant Fine FusionGEI2016-07-06
30161670963651K152441KIRO SetLHI2015-12-04
30161776225858K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25GCJ2014-12-23
30161980789748K142082ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENTDZE2014-10-28
30161941022957K141288VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICEGEI2014-08-22
30161031998426K133339ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATEDDZE2014-03-04
30161426264101K132602STREAMLINE EXPRESSKDI2014-02-04
30161820490869K132258ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEMDZE2013-11-19
30161703637829K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSHOZ2013-10-29
30161586725233K130097MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NSFMI2014-07-22
30161359083180K120191PUSH-ON NEEDLE 30GX8MMFMI2012-05-23
30161099763612K113753ZIMMER DENTAL TAPERED SCREW-VENT XDZE2012-08-30
30161911870251K113316DCS LACRIMAL STENTOKS2012-11-08
30161558122551K113092ZIMMER CONTOUR PROVISIONAL COPINGNHA2012-01-23
30162030093708K113023STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZERKDI2012-12-21
30161283305588K112160TAPERED SCREW-VENT X IMPLANTDZE2011-12-14
30161597997956K111889ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANTDZE2011-12-06
30161612210471K111853ANGLED TAPERED ABUTMENTNHA2011-12-08
30161301269229K111852ANODIZED HEALING COLLARNHA2011-08-11
30161394322065K110306SOUND SURGICAL VASER 2.1 LIPO SYSTEMQPB2011-06-23
30161288088140K103282LAPAROSCOPIC DISSECTORGEI2010-11-16
30161281260542K102547COROENT INTERLOCK SYSTEMOVE2011-02-07
30161988222832K102117TISSU TRANS FILTRON SYRINGE FILLMUU2010-08-06
30161156461643K101977TAPERED SCREW-VENT T IMPLANTDZE2010-09-14
30161671580811K101880TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANTDZE2010-10-01
30161989327440K101711CERULEAU ELECTROSURGICAL PROBEGEI2010-07-01
30161614950276K101545GENESIS IMPLANT SYSTEMDZE2010-10-28
30161931870842K101080NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXXGEI2010-06-21
30161259974665K100959SPECIMEN RETRIEVAL SYSTEMGCJ2010-04-22
30161651476655K100043COROENT XLR STANDALONE SYSTEMOVD2010-06-16
30161647294885K093804NUVASIVE HELIX REVOLUTION ACP SYSTEMKWQ2010-02-19
30161024694569K093562ENDOSSEOUS DENTAL IMPLANTDZE2010-10-14
30161648492508K0931643.25 SPLINE TWIST IMPLANT, HA COATEDDZE2009-12-15
30161458032520K092541INTERFACEMQV2010-11-09
30161883835181K092403TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620NHA2009-10-30
30161998329295K092377PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564SNHA2009-11-03
30161487103127K092022TISSU TRANS HARVEST TUBINGKYZ2009-08-17
30161292913654K091223VALLEYLAB SUCTION COAGULATOR, MODEL E3305GEI2009-09-11
30161638628659K091133APLION TOPICAL CARE SYSTEMNAD2009-05-20
30161822867274K090723HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,NHA2009-04-07
30161749421778K090707TALOS INTERVERTEBRAL BODY FUSION DEVICEMAX2009-07-15
30161706229180K090641CURIOSMQV2009-10-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE782014-10-28
NHA162012-01-23
GCJ132014-12-23
GEI122018-11-14
KWQ62010-02-19
DXC61996-11-04
EMX51995-12-22
FPA42009-04-10
HET42006-08-24
DXE41998-02-19
LHI32015-12-04
FMI22014-07-22
KDI22014-02-04
MQV22010-11-09
NAD22009-05-20
GWF22007-10-29
FZP22001-05-14
FGE21991-03-28
QBJ12019-02-14
QDL12018-11-02
QDK12018-10-26
HOZ12013-10-29
OKS12012-11-08
QPB12011-06-23
OVE12011-02-07
MUU12010-08-06
OVD12010-06-16
KYZ12009-08-17
MAX12009-07-15
ODP12009-01-13
MNI12008-04-07
MEB12008-02-19
GZT12006-07-26
MED12006-07-03
MQP12005-12-12
MRW12005-08-05
FHF12001-02-01
FED11999-12-28
FYA11999-10-15
LZK11996-06-28