Data / Medical devices / Canada / Integra Canada ULC

Integra Canada ULC: FDA-registered device maker in Oakville Ontario, Canada, 48 510(k) clearances and 1 PMA approval

Name: Integra Canada ULC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Integra Canada ULC is registered with the FDA (registration 3012507533) in Oakville Ontario, Canada. It lists 109 device types. The FDA files 48 510(k) clearances and 1 PMA approval under its listings, the newest dated June 23, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012507533
Address: 2590 Bristol Circle Unit 1, Oakville Ontario, Canada, L6H 6Z7
Owner or operator: Integra LifeSciences Corporation (9004007)
Roles: Exporter to the US
First device listed: February 24, 1981
Registered through: 2026
Brand names listed: 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25, 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38, 33-52;33-53;33-54;33-55;33-57, 4-110;4-111;4-112;4-112B;4-115;4-115C;4-120;4-121;4-122;4-123;4-125;4-310;4-311;4-312;4-312B;4-315;4-315C;4-320;4-321, 4-322;4-323;4-325;4610;4611;4615, 5-700;5-702;5801;5803;5804, 5-800, Alleghany CSF External Drainage Sys and more

Devices it lists

Device	Product code	Class	Role	Source
Blade, Scalpel	GES	1	Exporter to the US	accessdata.fda.gov
Block, Cutting, Ent, Non-Sterile	NNR	1	Exporter to the US	accessdata.fda.gov
Camera, Television, Surgical, With Audio	FWC	1	Exporter to the US	accessdata.fda.gov
Catheter, Ventricular	HCA	2	Exporter to the US	accessdata.fda.gov
Chisel, Nasal	KAN	1	Exporter to the US	accessdata.fda.gov
Clamp, Vascular	DXC	2	Exporter to the US	accessdata.fda.gov
Clip, Scalp	HBO	2	Exporter to the US	accessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	KNF	2	Exporter to the US	accessdata.fda.gov
Curette, Ear	JYG	1	Exporter to the US	accessdata.fda.gov
Curette, Nasal	KAP	1	Exporter to the US	accessdata.fda.gov
Curette, Periodontic	EMS	1	Exporter to the US	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Exporter to the US	accessdata.fda.gov
Curette, Uterine	HCY	1	Exporter to the US	accessdata.fda.gov
Cutter, Surgical	FZT	1	Exporter to the US	accessdata.fda.gov
Depressor, Metal Tongue, Surgical	KBL	1	Exporter to the US	accessdata.fda.gov
Device, Monitoring, Intracranial Pressure	GWM	2	Exporter to the US	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Exporter to the US	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Elevator, Ent	KAD	1	Exporter to the US	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Exporter to the US	accessdata.fda.gov
Excavator, Ear	JYH	1	Exporter to the US	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Exporter to the US	accessdata.fda.gov
Forceps	HTD	1	Exporter to the US	accessdata.fda.gov
Forceps, Articulation Paper	EFK	1	Exporter to the US	accessdata.fda.gov
Forceps, Biopsy, Gynecological	HFB	1	Exporter to the US	accessdata.fda.gov
Forceps, Dressing, Dental	EFL	1	Exporter to the US	accessdata.fda.gov
Forceps, Ent	KAE	1	Exporter to the US	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Exporter to the US	accessdata.fda.gov
Forceps, Obstetrical	HDA	2	Exporter to the US	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Exporter to the US	accessdata.fda.gov
Forceps, Surgical, Gynecological	HCZ	2	Exporter to the US	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Exporter to the US	accessdata.fda.gov
Gag, Mouth	KBN	1	Exporter to the US	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Exporter to the US	accessdata.fda.gov
Headrest, Neurosurgical	HBM	1	Exporter to the US	accessdata.fda.gov
Hemostat	HRQ	1	Exporter to the US	accessdata.fda.gov
Holder, Ear Speculum	JYK	1	Exporter to the US	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Exporter to the US	accessdata.fda.gov
Hook, Microsurgical Ear	JYL	1	Exporter to the US	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Exporter to the US	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Exporter to the US	accessdata.fda.gov
Instrument, Cast Application/Removal, Manual	LGG	1	Exporter to the US	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Exporter to the US	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Exporter to the US	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Exporter to the US	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Exporter to the US	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Exporter to the US	accessdata.fda.gov
Knife, Ear	JYO	1	Exporter to the US	accessdata.fda.gov
Knife, Ent	KTG	1	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Exporter to the US	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Exporter to the US	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Exporter to the US	accessdata.fda.gov
Needle, Aspiration And Injection, Reusable	GDM	1	Exporter to the US	accessdata.fda.gov
Neurosurgical Ultrasonic Instruments	LBK	U	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Osteotome	HWM	1	Exporter to the US	accessdata.fda.gov
Osteotome, Manual	GFI	1	Exporter to the US	accessdata.fda.gov
Pick, Microsurgical Ear	JYT	1	Exporter to the US	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Exporter to the US	accessdata.fda.gov
Pliers, Operative	EJY	1	Exporter to the US	accessdata.fda.gov
Probe And Director, Gastro-Urology	FGM	1	Exporter to the US	accessdata.fda.gov
Probe, Ent	KAK	1	Exporter to the US	accessdata.fda.gov
Punch, Adenoid	KBS	1	Exporter to the US	accessdata.fda.gov
Punch, Antrum	KAW	1	Exporter to the US	accessdata.fda.gov
Punch, Ent	KTF	1	Exporter to the US	accessdata.fda.gov
Punch, Nasal	KAY	1	Exporter to the US	accessdata.fda.gov
Punch, Surgical	LRY	1	Exporter to the US	accessdata.fda.gov
Rasp, Nasal	KBA	1	Exporter to the US	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Exporter to the US	accessdata.fda.gov
Retainer, Matrix	JEP	1	Exporter to the US	accessdata.fda.gov
Retractor	GAD	1	Exporter to the US	accessdata.fda.gov
Retractor, All Types	EIG	1	Exporter to the US	accessdata.fda.gov
Retractor, Ent	KAL	1	Exporter to the US	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Exporter to the US	accessdata.fda.gov
Retractor, Vaginal	HDL	1	Exporter to the US	accessdata.fda.gov
Rongeur	HTX	1	Exporter to the US	accessdata.fda.gov
Rongeur, Manual	HAE	2	Exporter to the US	accessdata.fda.gov
Rongeur, Mastoid	JZA	1	Exporter to the US	accessdata.fda.gov
Rongeur, Nasal	KBB	1	Exporter to the US	accessdata.fda.gov
Scissors, Ear	JZB	1	Exporter to the US	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Exporter to the US	accessdata.fda.gov
Scissors, Nasal	KBD	1	Exporter to the US	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Exporter to the US	accessdata.fda.gov
Sealant, Dural	NQR	3	Exporter to the US	accessdata.fda.gov
Shunt, Central Nervous System And Components	JXG	2	Exporter to the US	accessdata.fda.gov
Snare, Nasal	KBE	1	Exporter to the US	accessdata.fda.gov
Snare, Tonsil	KBZ	1	Exporter to the US	accessdata.fda.gov
Sound, Urethral, Metal Or Plastic	FBX	1	Exporter to the US	accessdata.fda.gov
Sound, Uterine	HHM	1	Exporter to the US	accessdata.fda.gov
Speculum, Ent	EPY	1	Exporter to the US	accessdata.fda.gov
Speculum, Rectal	FFQ	1	Exporter to the US	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Exporter to the US	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US	accessdata.fda.gov
Stripper, Surgical	HRT	1	Exporter to the US	accessdata.fda.gov
Syringe, Cartridge	EJI	2	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
Tenaculum, Uterine	HDC	2	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Ent	MMO	1	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Trocar, Ent	KTE	1	Exporter to the US	accessdata.fda.gov
Tube, Ear Suction	JZF	1	Exporter to the US	accessdata.fda.gov
Tube, Laryngectomy	KAC	1	Exporter to the US	accessdata.fda.gov
Tube, Tonsil Suction	KCB	1	Exporter to the US	accessdata.fda.gov
Twister, Wire	HXS	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 23, 2026	K261004	Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)	JXG	Substantially Equivalent	Integra Lifesciences Production Corporation	accessdata.fda.gov
February 4, 2024	K232890	CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)	GWM	Substantially Equivalent	Integra Lifesciences Production Corporation	accessdata.fda.gov
January 17, 2024	K233445	Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter	JXG	Substantially Equivalent	Integra Lifesciences Production Corporation	accessdata.fda.gov
May 14, 2021	K210942	MicroFrance Monopolar and Bipolar Electrosurgical Instruments	GEI	Substantially Equivalent	Integra Microfrance	accessdata.fda.gov
April 11, 2019	K183526	Codman Electrosurgical Generator, Foot Pedal	GEI	Substantially Equivalent	Kls Martin GmbH + Co. KG	accessdata.fda.gov
December 7, 2018	K182809	CUSA Clarity Ultrasonic Surgical Aspirator System	LFL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
November 27, 2018	K182801	Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable	GEI	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
November 20, 2018	K182265	CodMan Certas Plus Programmable Valve	JXG	Substantially Equivalent	Integra Lifesciences Corp.	accessdata.fda.gov
November 8, 2017	K173192	CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit	GWM	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
October 16, 2017	K172537	Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag	JXG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
October 26, 2016	K162469	CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps	GEI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
October 14, 2016	K161882	CUSA Clarity Ultrasonic Surgical Aspirator System	LFL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
August 19, 2016	K153347	Codman 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 Kit	GWM	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
October 27, 2015	K152152	Codman Certas Plus Programmable Valve	JXG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
April 16, 2015	K150428	Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs	HAE	Substantially Equivalent	Integra Lifesciences Corp.	accessdata.fda.gov
November 6, 2014	K141674	CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM	LFL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
April 11, 2014	K134047	JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS	HCZ	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
August 30, 2013	K131184	INTEGRA LICOX PTO2 MONITOR	GWM	Substantially Equivalent	Integra Lifesciences Corp.	accessdata.fda.gov
May 14, 2013	K123077	VASCULAR CLAMPS	DXC	Substantially Equivalent	Hebumedical GmbH	accessdata.fda.gov
September 11, 2012	K120012	INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS	GCJ	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
August 3, 2012	K122118	HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM	JXG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
June 7, 2012	K112090	BAHADIR STERILIZATION TRAYS	KCT	Substantially Equivalent	Bahadir USA Corp.	accessdata.fda.gov
February 18, 2011	K102961	HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM	JXG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
November 18, 2010	K102146	BAHADIR STERILIZATION TRAYS	KCT	Substantially Equivalent	Bahadir USA Corp.	accessdata.fda.gov
November 9, 2010	K102048	ATRAUMATIC VASCULAR CLAMPS	DXC	Substantially Equivalent	Geomed Medizin-Technik GmbH & Co. KG	accessdata.fda.gov
March 9, 2009	K083796	MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT	EJI	Substantially Equivalent	Miltex, Inc.	accessdata.fda.gov
November 21, 2008	K082349	JARIT HULKA UTERINE TENACULUM FORCEPS	HDC	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.	accessdata.fda.gov
May 22, 2008	K080257	MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS	GCJ	Substantially Equivalent	Medtronic Xomed, Inc.	accessdata.fda.gov
March 17, 2008	K073450	SUTTER ELECTROSURGICAL CABLES	GEI	Substantially Equivalent	Sutter Medizintechnik GmbH	accessdata.fda.gov
March 22, 2007	K070509	FISSO HOLDING SYSTEM	GCJ	Substantially Equivalent	Baitella AG	accessdata.fda.gov
October 16, 2006	K061876	CODMAN VPV SYSTEM, MODEL 82-3192	JXG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
July 19, 2006	K060233	TROKAMED GMBH ENDOSCOPES AND ACCESSORIES	GCJ	Substantially Equivalent	Trokamed GmbH	accessdata.fda.gov
January 19, 2006	K053107	CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD	JXG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
July 29, 2005	K051429	CLARIS NON-STICK BIPOLAR FORCEPS	GEI	Substantially Equivalent	Guenter Bissinger Medizintechnik GmbH	accessdata.fda.gov
June 10, 2004	K041296	MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI	JXG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
April 20, 2004	K040235	LICOX PMO BRAIN MONITORING SYSTEM	GWM	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
December 20, 2000	K003564	HAKIM PROGRAMMER AND TRANSMITTER	JXG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
December 21, 1999	K993655	MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS	GEI	Substantially Equivalent	Xomed, Inc.	accessdata.fda.gov
April 8, 1999	K982365	ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT	DXC	Substantially Equivalent	Geister Medizin Technik GmbH	accessdata.fda.gov
July 6, 1998	K981262	CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM	LFL	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov
October 8, 1996	K963499	MIRROR FINISH BIPOLAR FORCEPS	GEI	Substantially Equivalent	Johnson & Johnson Professionals, Inc.	accessdata.fda.gov
July 28, 1995	K944222	CODMAN-MEDOS VALVE SHUNT SYSTEM	JXG	Substantially Equivalent	Johnson & Johnson Professionals, Inc.	accessdata.fda.gov
May 16, 1994	K941541	HSV LAPAROSCOPY SET	GCJ	Substantially Equivalent	Henke Sass Wolf of America, Inc.	accessdata.fda.gov
April 21, 1994	K932456	JARIT SURGICAL INSTRUMENTS	KNF	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.	accessdata.fda.gov
November 10, 1993	K931928	JARIT SURGICAL INSTRUMENTS	GCJ	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.	accessdata.fda.gov
February 21, 1991	K905433	CODMAN DISPOSABLE SCALP CLIP APPLIER	HBO	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
September 20, 1990	K902818	MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT	HBG	Substantially Equivalent	Ruggles Corp.	accessdata.fda.gov
May 3, 1985	K851487	CODMAN DISPOSABLE BIPOLAR CARD	GEI	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 4, 2009	P080013	DURASEAL EXACT SPINE SEALANT SYSTEM	NQR	28	February 27, 2026	accessdata.fda.gov

Compare with other makers

Updated June 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.