FDA.reportPublic FDA data

Integra LifeSciences Production Corporation

Matched from indexed company URL: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30143340383014334038Integra LifeSciences Production Corporation1N2026-01-0111 Cabot Blvd. Mansfield MA US 02048

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10381780024507Integra® Jarit® - "Integra® Jarit® Universal Bandage Scissors, 6-1/2"", with Autoclavable Finger Rings, One Serrated Blade, Black"+1(800)654-2873custsvcnj@integralife.com
10381780024514Integra® Jarit® - "Integra® Jarit® Universal Bandage Scissors, 7-1/2"", with Autoclavable Finger Rings, One Serrated Blade, Black"+1(800)654-2873custsvcnj@integralife.com
10381780031901Integra® Miltex® - "Integra® Miltex® Kirschner Wires 12"", Trocar Point with Flat Chuck End, 0.035"" diameter"+1(800)654-2873custsvcnj@integralife.com
10381780031918Integra® Miltex® - "Integra® Miltex® Kirschner Wires 12"", Trocar Point with Flat Chuck End, 0.045"" diameter"+1(800)654-2873custsvcnj@integralife.com
10381780031925Integra® Miltex® - "Integra® Miltex® Kirschner Wires 12"", Trocar Point with Flat Chuck End, 0.0625"" diameter"+1(800)654-2873custsvcnj@integralife.com
10381780031932Integra® Miltex® - "Integra® Miltex® Kirschner Wires 7-1/2"", Trocar points, double-ended, 0.035"" diameter"+1(800)654-2873custsvcnj@integralife.com
10381780031949Integra® Miltex® - "Integra® Miltex® Kirschner Wires 7-1/2"", Trocar points, double-ended, 0.045"" diameter"+1(800)654-2873custsvcnj@integralife.com
10381780031956Integra® Miltex® - "Integra® Miltex® Kirschner Wires 7-1/2"", Trocar points, double-ended, 0.0625"" diameter"+1(800)654-2873custsvcnj@integralife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2180011276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
2180011776172260K992591CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITSGWM1999-10-15
2180011428097792K992173SIPHONGUARD CSF CONTROL DEVICEJXG2000-04-07
2180011088532226K991413CODMAN ETHISORB DURA PATCHGXQ2000-03-13
2180011093635698K991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITGWM1999-07-09
2180011783902218K982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERHCI1998-12-18
2180012017435437K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
2180011265329691K982294XOMED SILICONE PRE-FORM BLOCKSKHJ1998-09-18
2180011293444010K974739HAKIM PROGRAMMABLE VALVE SYSTEMJXG1998-07-01
2180011839003887K974088CODMAN INTRACRANIAL BOLTGWM1998-01-09
2180011505347487K973774CODMAN HAKIM MICRO PRECISION VALVEJXG1997-12-29
2180011085205304K970910XOMED SILICONE BLOCK/STRIPKHJ1997-05-02
2180011343517402K963499MIRROR FINISH BIPOLAR FORCEPSGEI1996-10-08
2180011874914182K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
2180011977942307K950646INTEGRATORLXM1996-04-30
2180011347427456K945585COMAN(R) CU-11 MODEL NUMBER 82-6634GWM1995-10-26
2180011630812658K944870JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680GCJ1994-11-02
2180011185205031K944222CODMAN-MEDOS VALVE SHUNT SYSTEMJXG1995-07-28
2180011670417272K941565JARIT RECOMMENDED SINUS INSTRUMENTSEOB1994-05-16
2180011953973647K934196CODMAN QUICK SHUNT KIT, CAT. #82-6570GWG1994-04-12
2180011973151328K933728JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339GEI1994-02-23
2180011920821367K932456JARIT SURGICAL INSTRUMENTSKNF1994-04-21
2180011811406224K931959JARIT SURGICAL INSTRUMENTSGEI1993-10-05
2180011545794415K931928JARIT SURGICAL INSTRUMENTSGCJ1993-11-10
2180011992844836K931878JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680GCJ1993-08-19
2180011256496502K931281MICRO ENDOSCOPIC ELECTRODE (ME2)GCJ1993-07-23
2180012038978903K914479MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCERGWM1994-03-07
2180011823732771K905433CODMAN DISPOSABLE SCALP CLIP APPLIERHBO1991-02-21
2180011092338336K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTHBG1990-09-20
2180011266190430K902544SUNDT AVM MICRO CLIPHCI1990-09-20
2180011949071716K896541MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-IIIGEI1990-01-29
2180011850202881K883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERGYK1988-09-30
2180011858207242K880402CODMAN SURGICAL PATTIEHBA1988-03-02
2180011545825924K875018GHAJAR GUIDE TWIST DRILLHBG1988-01-28
2180011140705657K864387LUXTEC FIBEROPTIC CABLESEQH1987-05-22
2180011569970218K864385LUXTEC LIGHT SOURCESFCW1987-01-13
2180011246898807K853770CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KITGWM1986-10-06
2180011865685775K851487CODMAN DISPOSABLE BIPOLAR CARDGEI1985-05-03
2180011125043242K840003DISPOSABLE ICP KIT DIFF. SIZESGWM1984-02-28
2180011091262307K834477DISPOS. SCOTT CANNULAS 16-1054 ETC.HCA1984-03-19
2180011731136963K791101DISPOSABLE PERFORATORS, JACOBS, HUDSONHBF1979-08-28
2180011902114912K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetJXG2023-12-19
2180011368725883K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterJXG2024-01-17
2180011393210386K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM2024-02-04
2180011051015535K223330Certas Plus Programmable ValvesJXG2023-02-01
2180011457802808K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesJXG2022-10-14
2180011845126550K210993CereLink ICP MonitorGWM2021-04-30
2180011793998257K193346Codman Surgical Patties & StripsHBA2020-11-20
2180011425293876K183581Codman Disposable PerforatorsHBF2019-01-20
2180011345997555K183526Codman Electrosurgical Generator, Foot PedalGEI2019-04-11
2180011915321853K183438Geomed Vascular DilatorsDWP2019-09-03
2180011657444927K183406CereLink ICP Monitor, CereLink ICP Extension CableGWM2019-01-11
2180011240253335K182801Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting CableGEI2018-11-27
2180011216066706K181902Codman Certas Plus Electronic Tool KitJXG2018-10-25
2180011693815661K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitGWM2017-11-08
2180011580077502K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagJXG2017-10-16
2180011701605965K170599SureFlo EVD CatheterJXG2017-08-31
2180011074127371K163106CODMAN Integrated Bipolar Cord and Tubing SetGEI2016-12-01
2180011687590741K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar ForcepsGEI2016-10-26
2180011871858685K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitGWM2016-08-19
2180011146067237K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesGWM2016-01-22
2180011318052059K152481DURAFORM Dural Graft ImplantGXQ2015-10-30
2180011529386886K152152Codman Certas Plus Programmable ValveJXG2015-10-27
2180011106900700K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison RongeursHAE2015-04-16
2180011422354150K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitJXG2015-02-19
2180011745461274K142414Miltex N-Tralig Intraligamentary SyringeEJI2014-10-30
2180011602032618K140722INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELSJXG2015-01-06
2180011943695468K134047JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPSHCZ2014-04-11
2180011559113950K131446INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESDQR2013-10-28
2180011371764804K123077VASCULAR CLAMPSDXC2013-05-14
2180011014898985K122118HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEMJXG2012-08-03
2180011669413470K120012INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTSGCJ2012-09-11
2180011286550419K113526CODMAN CERTAS PROGRAMMABLE VALVE SYSTEMJXG2012-02-16
2180012025305733K110751CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETERJXG2011-05-09
2180012020418372K103726JARIT TAKE-APART ENDOSCOPIC INSTRUMENTSKNF2012-02-08
2180011699518506K102961HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODMJXG2011-02-18
2180011475649943K102589CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETERJXG2011-01-14
2180011851102254K102048ATRAUMATIC VASCULAR CLAMPSDXC2010-11-09
2180011162480140K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESKCT2010-08-02
2180011196189534K093968OSV II LOW FLOW LOW PRO VALVEJXG2010-01-22
2180011889763245K092395OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEMJXG2009-11-19
2180011661610256K092227JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURSHAE2010-02-17
2180011731672422K091921CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPHCH2009-09-08
2180011030556986K091346CODMAN HAKIM MICRO II VALVEJXG2009-06-02
2180011533398381K090348CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SETJXG2009-03-04
2180011791310766K083895CODMAN ISOCOOL BIPOLAR FORCEPSGEI2009-06-23
2180011164768729K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTEJI2009-03-09
2180011256845851K082349JARIT HULKA UTERINE TENACULUM FORCEPSHDC2008-11-21
2180011653267825K081773OSV IIJXG2008-11-06
2180011624616522K081477LUXTEC MLX LIGHT SOURCEFCW2008-06-18
2180011967283977K073652ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLEEFB2008-03-20
2180011015965974K073336CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231HBF2008-01-04
2180011769163001K071931CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223HBF2007-10-22
2180011259692401K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280GXP2007-07-30
2180011843934010K061876CODMAN VPV SYSTEM, MODEL 82-3192JXG2006-10-16
2180011338155504K061568CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738JXG2006-09-29
2180011312316464K061271ERCH ARCH BAR, MODEL 38-690-00DYX2006-06-30
2180011612851940K053350MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMSJXG2006-01-19
2180011523342892K053244LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KITGWM2006-05-10
2180011245298057K053107CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARDJXG2006-01-19
2180011237549402K043013MILTEX LAPAROSCOPIC INSTRUMENTSHET2005-03-04
2180011575710423K042192LOW FLOW OSV II HYDROCEPHALUS VALVEJXG2004-09-02
2180011309384566K041518CODMAN DURAFORM DURAL GRAFT IMPLANTGXQ2004-06-22
2180012070471398K041296MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SIJXG2004-06-10
2180011344293041K040235LICOX PMO BRAIN MONITORING SYSTEMGWM2004-04-20
2180011188378649K032817EXTERNAL DRAINAGE SETJXG2003-10-06
2180011327420314K031123CODMAN BACTISEAL BARIUM STRIPED CATHETERSHCA2003-05-14
2180011925043099K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSDWP2003-07-12
2180012019362833K023566CODMAN ISOCOOL BIPOLAR FORCEPSGEI2003-05-22
2180011153552524K021653CODMAN BACTISEAL EVD CATHETER SETJXG2002-07-29
2180011510826916K020667CODMAN HAKIM SHUNT SYSTEMSJXG2002-03-28
2180011456510645K003564HAKIM PROGRAMMER AND TRANSMITTERJXG2000-12-20
2180011297645215K003322CODMAN BACTISEAL CATHETERSHCA2001-10-01
2180011595200704K002765LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPEGWM2000-11-24
2180011028089420
2180011156010322
2180011198694897
2180011203479044
2180011304182435
2180011313848267

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG342024-01-17
GWM162024-02-04
GEI122019-04-11
GCJ52012-09-11
HBF42019-01-20
GXQ32015-10-30
DXC32013-05-14
HCA32003-05-14
HBA22020-11-20
DWP22019-09-03
HAE22015-04-16
EJI22014-10-30
KNF22012-02-08
FCW22008-06-18
HCI21998-12-18
KHJ21998-09-18
HBG21990-09-20
HCZ12014-04-11
DQR12013-10-28
KCT12010-08-02
HCH12009-09-08
HDC12008-11-21
EFB12008-03-20
GXP12007-07-30
DYX12006-06-30
HET12005-03-04
EGS11996-09-12
LXM11996-04-30
EOB11994-05-16
GWG11994-04-12
HBO11991-02-21
GYK11988-09-30
EQH11987-05-22

PMN#

GUDID#

200 records. Showing 1-40. Next