Isomedix Operations, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1424263	3003015552	Isomedix Operations, Inc.	1	N	2026-01-01	2500 Commerce Dr Libertyville IL US 60048
1450662	1450662	Isomedix Operations, Inc.	1	N	2026-01-01	1880 Industrial Dr Libertyville IL US 60048
2030624	3000206435	Isomedix Operations, Inc.	1	N	2026-01-01	43425 Business Park Dr Temecula CA US 92590
2183744	2183744	Isomedix Operations, Inc.	1	N	2026-01-01	380 90TH AVE NW Minneapolis MN US 55433

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
3005	1102041546	P980031	INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS	LQE	1999-04-09
3005	1096677103	P960016	LIVEWIRE(R) CARDIAC ABLATION SYSTEM	LPB	1999-05-04
3005	1090575799	P950002	BAK INTERBODY FUSION SYSTEM	MAX	1996-09-20
3005	1039464221	P930038	Angio Seal Vascular Closure Device	MGB	1996-09-30
3005	1587007464	P870076	FALOPE RING BAND AND APPLICATOR SYSTEMS	KNH	1993-09-29
3015	1191843395	P850045
3015	1113155575	P830055	LCS(R) TOTAL KNEE SYSTEM	NJL	1985-04-12
3015	1084395294	P810040	SUPERSTAT	LMF	1982-01-29
3005	1955623856	P810002	BILEAFLET-CENTER OPENING CARDIAC VALVE	LWQ	1982-12-17
3015	1234164580	P150022	CLOSER VASCULAR SEALING SYSTEM	MGB	2016-02-12
3005	1740284584	P130026	TACTICATH QUARTZ SET	OAE	2014-10-24
3005	2056057772	P130024	LUTONIX DRUG COATED BALLOON PTA CATETER	ONU	2014-10-09
3005	1106037758	P120021	AMPLATZER PFO OCCLUDER	MLV	2016-10-28
3005	2018586505	P110016	THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR	OAD	2012-01-25
3012	1746949917	P050039	NOVATION CERAMIC ARTICULATION HIP SYSTEM	MRA	2007-07-05
3012	1679883136	P050038	ARISTA AH ABSORBABLE HEMOSTAT	LMG	2006-09-26
3005	1844953192	P040040	AMPLATZER MUSCULAR VSD OCCLUDER	MLV	2007-09-07
3005	1495150166	P030045	INTRASTENT DOUBLESTRUT STENT	NIO	2004-06-08
3012	1006387762	P020049	PROCOL VASCULAR BIOPROSTHESIS	LXA	2003-07-29
3005	1444979019	P020025	EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM	OAD	2003-08-25
3005	1909816480	P020024	AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM	MAE	2003-05-14
3005	1593628620	P010047	PROGEL PLEURAL AIR LEAK SEALANT	NBE	2010-01-14
3005	2056490075	P000039	THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM	MLV	2001-12-05
3005	1838299154	P000033	INTRA COIL SELF-EXPANDING PERIPHERAL STENT	NIP	2002-04-03
3005	1184446221	K994216	PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM	LJT	2000-01-27
3005	1439168832	K994097	MEDAMICUS EPIDURAL INTRODUCER	GZB	2000-03-01
3012	1787276433	K993649	EBI XFIX DFS WRISTFIX SYSTEM	KTT	1999-11-19
3015	2000523102	K993239	STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX	HAW	2000-01-18
3012	2000523102	K993239	STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX	HAW	2000-01-18
3005	1099076879	K992816	MODIFICATION TO INTRASTENT	FGE	1999-10-15
3015	1121113778	K992617	HEX BUTTON	HTN	1999-10-27
3012	1273410379	K992367	EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS	HWC	1999-09-23
3014	1104121458	K992083	SCATTERFREE LATERAL EMITTING FIBER	GEX	1999-07-12
3015	1265943607	K992065	GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD	KWS	1999-07-12
3015	1653936677	K991947	3I CERAMIC ABUTMENT SYSTEM	DZE	1999-09-29
3012	1653936677	K991947	3I CERAMIC ABUTMENT SYSTEM	DZE	1999-09-29
3012	1807832474	K991294	MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM	KZE	1999-04-23
3014	1264491160	K991219	C-FLEX URETERAL STENTS	FAD	1999-06-21
3012	1777124076	K990197	MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM	MEH	1999-02-04
3015	1886754532	K984541	GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD	KWT	1999-01-14
3012	1633548407	K983491	DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER	LPH	1998-12-02
3014	1071118484	K982702	VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD	GWM	1998-09-10
3014	1613694228	K981846	PARENCHYMAL BOLT PRESSURE MONITORING KIT	GWM	1998-08-18
3005	1960585667	K981612	ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER	EZL	1998-07-08
3014	1291900282	K980987	BECTON DICKINSON SYRINGE	FMF	1998-06-11
3015	1722395016	K980513	ARTICUL/EZE FEMORAL HEADS	JDI	1998-04-14
3005	1441546226	K974471	PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A	LJT	1998-01-22
3014	1053706403	K974229	LS-905 FIBERCHOICE ADAPTER SYSTEM	GEX	1998-02-10
3015	1538631033	K974016	CERCLAGE CABLE WITH HEX BUTTON	JDQ	1997-12-19
3005	1053230183	K973840	FAST-CATH (TM) INTRA-CARDIAC INTRODUCER	DYB	1998-05-21
3005	1704418178	K973713	22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR	ITX	1998-01-23
3014	1157450922	K973465	LATIS GRAFT CLEANING CATHETER	DXE	1998-02-19
3015	1734237927	K973195	TOTAL PERFORMANCE SYSTEM SHAVER	HRX	1997-10-24
3012	1710273724	K972860	CURVTEK TSR SYSTEM	HSZ	1997-10-31
3015	1565761783	K972584	STRYKER HUMMER II MICRODEBRIDER SYSTEM	ERL	1997-10-01
3015	1593856191	K972444	3I INNOVATIVE IMPLANTS AND COVER SCREWS	DZE	1997-08-26
3014	1921255519	K972272	LASER PERIPHERALS HOLMIUM BARE FIBERS	GEX	1997-07-29
3015	1639791161	K972233	STRYKER WEDGE INTERFERENCE SCREW SYSTEM	HWC	1997-08-05
3015	1395263239	K972069	STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK	FQH	1997-07-29
3005	1849651421	K971627	SILICONE ANTIBACTERIAL FOLEY CATHETER	MJC	1998-01-13
3005	1981148125	K971571	RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT	KDN	1997-07-29
3014	1288994091	K970762	DUAL LUMEN EMBOLECTOMY CATHETER	DXE	1997-03-28
3012	1736130728	K970714	STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)	CAC	1997-12-16
3015	1849253858	K970485	SMARTSITE ACCESS PIN	FPA	1997-04-21
3012	1926981354	K964880	VARI-ANGLE HIP SCREW (VHS) SYSTEM	KTT	1997-10-16
3005	1711581422	K964518	FAST-CATH TRANSSEPTAL CATHETER INTRODUCER	DYB	1997-05-14
3005	1420099831	K964224	STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE	GYC	1997-03-19
3005	1138357208	K963989	P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE	ITX	1997-04-24
3015	1686021109	K963332	THERMO-PLASTIC SHAVER BLADES	HRX	1996-10-11
3012	1853775222	K963313	EXACTECH ALL POLY ACETABULAR CUP	JDI	1996-11-14
3005	1516645307	K962695	PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER	LJT	1996-10-01
3012	1818110093	K962002	AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM	JDG	1996-08-08
3012	1363824402	K961918	MULTI-TEST II	SCL	1996-08-07
3005	1854181016	K961580	PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS	LJT	1996-09-20
3005	1575674126	K961516	LASER PERIPHERALS INC. BARE FIBER	GEX	1996-06-27
3015	1146512922	K961267	PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE	JDQ	1996-06-27
3005	1582287605	K961079	LASER PERIPHERALS INC. SCATTERFREE FIBER	GEX	1996-05-22
3015	1167229584	K960810	BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM	HET	1996-10-21
3012	1224613608	K960617	ADVANCE TIBIAL COMPONENT	HRY	1996-05-08
3012	1155655352	K960538	OPTEON UNIPOLAR	KWL	1996-03-27
3015	1634207618	K960280	IVAC NEEDLE FREE VALVE ADMINISTRATION SETS	FPA	1996-04-04
3005	1127428727	K955407	PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS	LJT	1996-02-12
3015	1578256159	K954770	CENTRA-LINE GRAPPLE, VARIFIX SYSTEM	KWP	1996-01-25
3015	1370131868	K954726	STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)	GCX	1995-11-29
3005	1397441390	K954317	DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS	DYB	1995-11-28
3015	1300231053	K953778	SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM	MNH	1995-11-06
3015	1685728500	K952460	STRYKER ACL INTERFERENCE SCREW SYSTEM	HWC	1995-09-28
3015	1408973721	K952224	STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)	CAC	1995-11-17
3015	1761617882	K950685	BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING	KMF	1995-06-09
3005	1736014166	K950455	DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES	JOS	1995-05-16
3015	1986712358	K944320	VENTED/NON-VENTED GEMINI ADMINISTRATION SET	FPA	1995-02-14
3014	1689656108	K944135	UROLOGICAL GUIDWIRE	KNY	1994-09-21
3015	1010856774	K943834	STERILE .9% SODIUM CHLORIDE SOLUTION	JOL	1994-11-21
3015	1414627558	K943832	STERILE .9% SODIUM CHLORIDE FOR IRRATION	JOL	1994-11-21
3015	1612167421	K943830	PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION	JOL	1994-11-21
3015	1168517181	K943828	STERILE WATER FOR IRRIGATION	JOL	1994-11-21
3012	1193813893	K943698	STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES	MKJ	1994-12-28
3015	1747765399	K942387	SELBY INSTRUMENTATION	MNH	1995-02-14
3005	1345791692	K942024	PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM	LJT	1994-07-26
3012	1085099936	K941820	DUOTIP-TEST	SCL	1994-09-02
3015	1416861196	K941605	STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH	LXH	1994-08-05
3015	1916187970	K941333	SE5 ARTHROSCOPY SYTEM	HRX	1994-11-10
3014	1405388646	K941012	LOW PRESSURE TAMPONADE BALLOON CATHETER	EYB	1994-04-18
3005	1090816146	K940804	SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION	ITX	1994-06-10
3015	2063826757	K940729	PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES	JDQ	1994-12-21
3012	1318849457	K936079	ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT	JWH	1994-09-07
3005	1166234928	K935947	HI-TOPS ELECTRODES 14-8000	KNF	1994-02-28
3005	1130362709	K935499	PMT SILICONE SHEETING	MDA	1994-02-10
3015	1852004686	K934469	ARTHROTEK INTERFERENCE SCREW	HWC	1994-02-23
3012	1434609379	K934253	EXACTECH ALL POLY ACETABULAR CUP	JDZ	1994-04-29
3014	1440117828	K934095	IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS	FPA	1994-08-10
3015	1429107814	K934094	STRYKER LAPAROSCOPIC SUCTION IRRIGATOR	GCJ	1994-02-18
3012	1992692601	K933933	CEBOPLANE	HTZ	1994-04-15
3005	1160156125	K932977	CABOT MEDICAL OPTIMA HAND INSTRUMENTS	GCJ	1993-09-07
3005	1944958835	K932976	CABOT MEDICAL OPTIMA HAND INSTRUMENTS	GCJ	1993-09-07
3005	1346301918	K932841	PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS	LJT	1994-01-05
3005	1385784275	K932840	PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM	LJT	1994-01-05
3015	1019810177	K932123	IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM	DZE	1994-05-27
3012	1019810177	K932123	IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM	DZE	1994-05-27
3005	1119430157	K932095	PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S	LJT	1994-01-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DYB	24	2019-08-01
DZE	24	2015-11-20
DQY	21	2017-06-07
FPA	21	2014-08-29
QEZ	19	2018-09-11
LRC	15	2015-11-20
MQV	15	2015-01-14
JDI	15	2009-12-17
GEX	14	2017-06-08
MAX	13	2017-10-23
LJT	12	2007-12-14
DRF	10	2016-05-06
HWC	10	2011-07-28
LPH	10	2010-11-05
GEI	9	2015-01-13
MBI	9	2013-06-20
FGE	9	2006-08-31
NLQ	8	2019-08-15
JDQ	8	2018-10-12
QSY	8	2012-11-15
DQX	8	2010-09-23
QEW	7	2019-11-15
NUJ	7	2016-09-20
HIF	6	2017-11-14
HRS	6	2016-07-26
NLM	6	2014-01-22
NEU	5	2018-08-02
OZT	5	2015-12-18
MCW	5	2013-04-10
GCJ	5	2013-01-24
FRO	5	2012-07-09
KWA	5	2009-03-06
JDL	5	2006-12-06
HAW	5	2004-10-04
JOL	5	1994-11-21
DRA	4	2019-10-04
KRD	4	2019-04-17
MBF	4	2019-01-22
NRB	4	2014-08-13
FTL	4	2012-01-25