FDA.report

Integra Canada ULC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30125075333012507533Integra Canada ULC1N2026-01-012590 Bristol Circle Unit 1 Oakville Ontario CA L6H 6Z7

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2904941989060182P080013DURASEAL EXACT SPINE SEALANT SYSTEMNQR2009-09-04
2904941276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
2904942017435437K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
2904941408053185K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL1998-07-06
2904941343517402K963499MIRROR FINISH BIPOLAR FORCEPSGEI1996-10-08
2904941185205031K944222CODMAN-MEDOS VALVE SHUNT SYSTEMJXG1995-07-28
2904941195295229K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2904941920821367K932456JARIT SURGICAL INSTRUMENTSKNF1994-04-21
2904941545794415K931928JARIT SURGICAL INSTRUMENTSGCJ1993-11-10
2904941823732771K905433CODMAN DISPOSABLE SCALP CLIP APPLIERHBO1991-02-21
2904941092338336K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTHBG1990-09-20
2904941865685775K851487CODMAN DISPOSABLE BIPOLAR CARDGEI1985-05-03
2904941368725883K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterJXG2024-01-17
2904941393210386K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM2024-02-04
2904942001303989K210942MicroFrance Monopolar and Bipolar Electrosurgical InstrumentsGEI2021-05-14
2904941345997555K183526Codman Electrosurgical Generator, Foot PedalGEI2019-04-11
2904941755722249K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2018-12-07
2904941240253335K182801Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting CableGEI2018-11-27
2904941878737732K182265CodMan Certas Plus Programmable ValveJXG2018-11-20
2904941693815661K173192CereLink 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
2904941580077502K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagJXG2017-10-16
2904941687590741K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar ForcepsGEI2016-10-26
2904942016034898K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2016-10-14
2904941871858685K153347Codman 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
2904941529386886K152152Codman Certas Plus Programmable ValveJXG2015-10-27
2904941106900700K150428Integra (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
2904941892720264K141674CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2014-11-06
2904941943695468K134047JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPSHCZ2014-04-11
2904941230482150K131184INTEGRA LICOX PTO2 MONITORGWM2013-08-30
2904941371764804K123077VASCULAR CLAMPSDXC2013-05-14
2904941014898985K122118HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEMJXG2012-08-03
2904941669413470K120012INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTSGCJ2012-09-11
2904941836287221K112090BAHADIR STERILIZATION TRAYSKCT2012-06-07
2904941699518506K102961HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODMJXG2011-02-18
2904942057654668K102146BAHADIR STERILIZATION TRAYSKCT2010-11-18
2904941851102254K102048ATRAUMATIC VASCULAR CLAMPSDXC2010-11-09
2904941164768729K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTEJI2009-03-09
2904941256845851K082349JARIT HULKA UTERINE TENACULUM FORCEPSHDC2008-11-21
2904941921121724K080257MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTSGCJ2008-05-22
2904941101794646K073450SUTTER ELECTROSURGICAL CABLESGEI2008-03-17
2904941538589518K070509FISSO HOLDING SYSTEMGCJ2007-03-22
2904941843934010K061876CODMAN VPV SYSTEM, MODEL 82-3192JXG2006-10-16
2904941534676807K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJ2006-07-19
2904941245298057K053107CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARDJXG2006-01-19
2904941628599486K051429CLARIS NON-STICK BIPOLAR FORCEPSGEI2005-07-29
2904942070471398K041296MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SIJXG2004-06-10
2904941344293041K040235LICOX PMO BRAIN MONITORING SYSTEMGWM2004-04-20
2904941456510645K003564HAKIM PROGRAMMER AND TRANSMITTERJXG2000-12-20
2904941002506365
2904941003603889
2904941005134996
2904941012811137
2904941029764925
2904941037177068
2904941048191559
2904941050733655
2904941056287564
2904941070497949
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2904941075911886
2904941079093847
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2904941105110666
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2904941188387908
2904941206763984
2904941236261955
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2904941302239087
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2904941352490247
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2904941475295102
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2904941488213417
2904941492373715
2904941495207482
2904941577252184
2904941630803364
2904941635654464
2904941644767834
2904941653416027
2904941660544433
2904941671378273
2904941685672058
2904941704039002
2904941706277950
2904941707676113
2904941726549691
2904941740158376
2904941746983065
2904941755042341

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JXG112024-01-17
GEI92021-05-14
GCJ62012-09-11
GWM52024-02-04
LFL42018-12-07
DXC32013-05-14
KCT22012-06-07
HAE12015-04-16
HCZ12014-04-11
NQR12009-09-04
EJI12009-03-09
HDC12008-11-21
KNF11994-04-21
HBO11991-02-21
HBG11990-09-20