Data / Medical devices / United States / Integra LifeSciences Production Corporation
Integra LifeSciences Production Corporation: FDA-registered device maker in Mansfield, MA, United States, 94 510(k) clearances
Integra LifeSciences Production Corporation is registered with the FDA (registration 3014334038) in Mansfield, MA, United States. It lists 273 device types. The FDA files 94 510(k) clearances under its listings, the newest dated June 23, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014334038
- Address
- 11 Cabot Blvd., Mansfield, MA, United States, 02048
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- February 24, 1981
- Registered through
- 2026
- Brand names listed
- 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710, 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 and more
Devices it lists
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 |
| December 19, 2023 | K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| February 1, 2023 | K223330 | Certas Plus Programmable Valves | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| October 14, 2022 | K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| April 30, 2021 | K210993 | CereLink ICP Monitor | GWM | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| November 20, 2020 | K193346 | Codman Surgical Patties & Strips | HBA | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| April 11, 2019 | K183526 | Codman Electrosurgical Generator, Foot Pedal | GEI | Substantially Equivalent | Kls Martin GmbH + Co. KG | accessdata.fda.gov |
| January 20, 2019 | K183581 | Codman Disposable Perforators | HBF | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| January 11, 2019 | K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | GWM | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| November 27, 2018 | K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | GEI | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 25, 2018 | K181902 | Codman Certas Plus Electronic Tool Kit | 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 3, 2017 | K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| August 31, 2017 | K170599 | SureFlo EVD Catheter | JXG | Substantially Equivalent | Arkis Biosciences, Inc. | accessdata.fda.gov |
| December 1, 2016 | K163106 | CODMAN Integrated Bipolar Cord and Tubing Set | GEI | Substantially Equivalent | Medos International SARL | 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 |
| 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 |
| January 22, 2016 | K152670 | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables | GWM | Substantially Equivalent | Medos International SARL | 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 |
| February 19, 2015 | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | JXG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| January 6, 2015 | K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 30, 2014 | K142414 | Miltex N-Tralig Intraligamentary Syringe | EJI | 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 |
| October 28, 2013 | K131446 | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES | DQR | Substantially Equivalent | Integra LifeSciences Corporation | 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 |
| February 8, 2012 | K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | KNF | Substantially Equivalent | Integra LifeSciences Corporation | 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 |
| January 14, 2011 | K102589 | CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| August 2, 2010 | K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | KCT | Substantially Equivalent | Miltex, Inc. | accessdata.fda.gov |
| February 17, 2010 | K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | HAE | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| January 22, 2010 | K093968 | OSV II LOW FLOW LOW PRO VALVE | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 19, 2009 | K092395 | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM | JXG | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| June 23, 2009 | K083895 | CODMAN ISOCOOL BIPOLAR FORCEPS | GEI | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| June 2, 2009 | K091346 | CODMAN HAKIM MICRO II VALVE | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | 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 |
| March 4, 2009 | K090348 | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| November 21, 2008 | K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | HDC | Substantially Equivalent | J. Jamner Surgical Instruments, Inc. | accessdata.fda.gov |
| November 6, 2008 | K081773 | OSV II | JXG | Substantially Equivalent | Integra Neurosciences Implants S.A. | accessdata.fda.gov |
| June 18, 2008 | K081477 | LUXTEC MLX LIGHT SOURCE | FCW | Substantially Equivalent | Integra Luxtec, Inc. | accessdata.fda.gov |
| January 4, 2008 | K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | HBF | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 22, 2007 | K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | HBF | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 16, 2006 | K061876 | CODMAN VPV SYSTEM, MODEL 82-3192 | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| September 29, 2006 | K061568 | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| May 10, 2006 | K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | GWM | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| January 19, 2006 | K053350 | MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| January 19, 2006 | K053107 | CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| March 4, 2005 | K043013 | MILTEX LAPAROSCOPIC INSTRUMENTS | HET | Substantially Equivalent | Miltex, Inc. | accessdata.fda.gov |
| September 2, 2004 | K042192 | LOW FLOW OSV II HYDROCEPHALUS VALVE | JXG | Substantially Equivalent | Integra Neurosciences Implants S.A. | 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 |
| May 14, 2003 | K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | HCA | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| July 29, 2002 | K021653 | CODMAN BACTISEAL EVD CATHETER SET | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| March 28, 2002 | K020667 | CODMAN HAKIM SHUNT SYSTEMS | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 1, 2001 | K003322 | CODMAN BACTISEAL CATHETERS | HCA | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| December 20, 2000 | K003564 | HAKIM PROGRAMMER AND TRANSMITTER | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| November 24, 2000 | K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | GWM | Substantially Equivalent | Integra Neurosciences | accessdata.fda.gov |
| April 7, 2000 | K992173 | SIPHONGUARD CSF CONTROL DEVICE | JXG | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| December 21, 1999 | K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | GEI | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| October 15, 1999 | K992591 | CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| July 9, 1999 | K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | GWM | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| September 18, 1998 | K982294 | XOMED SILICONE PRE-FORM BLOCKS | KHJ | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| July 1, 1998 | K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | JXG | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| January 9, 1998 | K974088 | CODMAN INTRACRANIAL BOLT | GWM | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| May 2, 1997 | K970910 | XOMED SILICONE BLOCK/STRIP | KHJ | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| October 8, 1996 | K963499 | MIRROR FINISH BIPOLAR FORCEPS | GEI | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| April 30, 1996 | K950646 | INTEGRATOR | LXM | Substantially Equivalent | Moyco Union Broach, Div., Moyco Technologies, Inc. | accessdata.fda.gov |
| October 26, 1995 | K945585 | COMAN(R) CU-11 MODEL NUMBER 82-6634 | GWM | 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 |
| November 2, 1994 | K944870 | JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 | GCJ | Substantially Equivalent | J. Jamner Surgical Instruments, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941565 | JARIT RECOMMENDED SINUS INSTRUMENTS | EOB | Substantially Equivalent | J. Jamner Surgical Instruments, Inc. | accessdata.fda.gov |
| April 21, 1994 | K932456 | JARIT SURGICAL INSTRUMENTS | KNF | Substantially Equivalent | J. Jamner Surgical Instruments, Inc. | accessdata.fda.gov |
| March 7, 1994 | K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| February 23, 1994 | K933728 | JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339 | GEI | 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 |
| October 5, 1993 | K931959 | JARIT SURGICAL INSTRUMENTS | GEI | Substantially Equivalent | J. Jamner Surgical Instruments, Inc. | accessdata.fda.gov |
| August 19, 1993 | K931878 | JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 | 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 |
| January 29, 1990 | K896541 | MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III | GEI | Substantially Equivalent | Valley Forge Scientific Corp. | accessdata.fda.gov |
| September 30, 1988 | K883607 | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | GYK | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| March 2, 1988 | K880402 | CODMAN SURGICAL PATTIE | HBA | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| January 28, 1988 | K875018 | GHAJAR GUIDE TWIST DRILL | HBG | Substantially Equivalent | Neurodynamics, Inc. | accessdata.fda.gov |
| May 22, 1987 | K864387 | LUXTEC FIBEROPTIC CABLES | EQH | Substantially Equivalent | Luxtec Corp. | accessdata.fda.gov |
| January 13, 1987 | K864385 | LUXTEC LIGHT SOURCES | FCW | Substantially Equivalent | Luxtec Corp. | accessdata.fda.gov |
| October 6, 1986 | K853770 | CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| May 3, 1985 | K851487 | CODMAN DISPOSABLE BIPOLAR CARD | GEI | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| March 19, 1984 | K834477 | DISPOS. SCOTT CANNULAS 16-1054 ETC. | HCA | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| February 28, 1984 | K840003 | DISPOSABLE ICP KIT DIFF. SIZES | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| August 28, 1979 | K791101 | DISPOSABLE PERFORATORS, JACOBS, HUDSON | HBF | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
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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.