Data / Medical devices / United States / Integra Lifesciences Corporation
Integra Lifesciences Corporation: FDA-registered device maker in Cincinnati, OH, United States, 58 510(k) clearances
Integra Lifesciences Corporation is registered with the FDA (registration 3004608878) in Cincinnati, OH, United States. It lists 184 device types. The FDA files 58 510(k) clearances under its listings, the newest dated September 3, 2019. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004608878
- Address
- 4900 Charlemar DR., Building A, Cincinnati, OH, United States, 45227
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- 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, Acclarent 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 |
|---|---|---|---|---|---|---|
| September 3, 2019 | K183438 | Geomed Vascular Dilators | DWP | Substantially Equivalent | Geomed Medizin-Technik GmbH & Co. | accessdata.fda.gov |
| December 7, 2018 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 6, 2016 | K160811 | CRW STEREOTACTIC SYSTEM | HAW | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 14, 2016 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | 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 20, 2015 | K150024 | Bissinger Monopolar Cables | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| November 24, 2014 | K142238 | MAYFIELD Skull Clamp | HBL | Substantially Equivalent | Integra LifeSciences Corporation | 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 |
| May 14, 2013 | K123077 | VASCULAR CLAMPS | DXC | Substantially Equivalent | Hebumedical GmbH | accessdata.fda.gov |
| April 23, 2013 | K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| June 7, 2012 | K112090 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| May 24, 2012 | K120633 | MAYFIELD SKULL CLAMP | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| January 20, 2012 | K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP | DXC | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| December 20, 2011 | K102921 | ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES | GEI | Substantially Equivalent | Bema-GmbH & Co. KG | 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 |
| August 2, 2010 | K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | KCT | Substantially Equivalent | Miltex, Inc. | accessdata.fda.gov |
| April 8, 2010 | K100417 | XKNIFE 5 | MUJ | Substantially Equivalent | Integra Radionics, Inc. | accessdata.fda.gov |
| October 2, 2009 | K091721 | CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 | GEH | Substantially Equivalent | New Medical Technologies GmbH | accessdata.fda.gov |
| April 20, 2009 | K090506 | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 21, 2008 | K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | HDC | Substantially Equivalent | J. Jamner Surgical Instruments, Inc. | accessdata.fda.gov |
| October 8, 2008 | K081401 | MAYFIELD MR/X-RAY SKULL CLAMP | HBL | Substantially Equivalent | Integra Lifesciences Corp. | 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 |
| September 7, 2007 | K072208 | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| June 13, 2007 | K071458 | MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| March 22, 2007 | K070509 | FISSO HOLDING SYSTEM | GCJ | Substantially Equivalent | Baitella AG | accessdata.fda.gov |
| July 19, 2006 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| November 23, 2005 | K052745 | ASSISTO ARM SYSTEMS | GWG | Substantially Equivalent | Geomed Medizin-Technik GmbH & Co. | accessdata.fda.gov |
| September 20, 2005 | K051440 | MAYFIELD INFINITY SKULL CLAMP | HBL | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| July 29, 2005 | K051429 | CLARIS NON-STICK BIPOLAR FORCEPS | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| March 31, 2005 | K050319 | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 | HBL | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| September 15, 2003 | K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | HAW | Substantially Equivalent | Radionics, A Division of Tyco Healthcare Group LP | accessdata.fda.gov |
| July 12, 2003 | K030788 | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | DWP | Substantially Equivalent | Geister Medizin Technik GmbH | accessdata.fda.gov |
| March 12, 2001 | K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | HAW | Substantially Equivalent | Radionics, A Division of Tyco Healthcare Group LP | accessdata.fda.gov |
| June 9, 2000 | K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | HET | Substantially Equivalent | Xomed, 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 |
| August 6, 1998 | K981919 | BISSINGER CABLES, CAT. NO. 801000XX | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| August 22, 1996 | K962155 | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY | IYE | Substantially Equivalent | Radionics Software Applications, Inc. | accessdata.fda.gov |
| August 7, 1996 | K961858 | COSGROVE DEPTH ELECTRODE KIT(CDEK) | HAW | Substantially Equivalent | Radionics, Inc. | accessdata.fda.gov |
| February 9, 1996 | K953124 | MAYFIELD RADIOLUCENT 2000 SKULL CLAMP | HBL | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
| December 6, 1995 | K941558 | MAYFIELD CHILD DISPOSABLE SKULL PIN | HBL | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
| October 26, 1995 | K944463 | CRW-1 SYSTEM | HAW | Substantially Equivalent | Radionics Software Applications, Inc. | accessdata.fda.gov |
| February 23, 1995 | K945266 | OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES | GCJ | Substantially Equivalent | Optus, 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 | 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 |
| 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 |
| September 28, 1993 | K932860 | MAYFIELD ADULT DISPOSABLE SKULL PIN | HBL | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
| September 28, 1993 | K932807 | MAYFIELD* A-2000 SKULL CLAMP | HBL | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
| February 12, 1993 | K923789 | MAYFIELD ADULT DISPOSABLE SKULL PIN | HBL | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
| September 20, 1990 | K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | HBG | Substantially Equivalent | Ruggles Corp. | accessdata.fda.gov |
| August 7, 1989 | K890765 | STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| November 19, 1986 | K864380 | LUTEX HEADLIGHT SYSTEMS | FST | Substantially Equivalent | Luxtec Corp. | accessdata.fda.gov |
| March 2, 1983 | K830332 | BUDDE-HALO RETRACTOR | GZT | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 19, 2014 | 70088 | Class II | Terminated | The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park- | Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use. | accessdata.fda.gov |
| November 5, 2012 | 63776 | Class II | Terminated | MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used t | An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the | accessdata.fda.gov |
| May 19, 2010 | 55852 | Not yet classified | Terminated | Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient | Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but were inadvertently placed on the Infinity XR2 Base Unit storage cases. | accessdata.fda.gov |
| March 1, 2010 | 55242 | Not yet classified | Terminated | Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. | Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device). | accessdata.fda.gov |
| February 8, 2010 | 54618 | Not yet classified | Terminated | Qwix 4.3mm Stabilization Screws - 32mm | The screws were etched incorrectly as 34mm instead of the correct 32mm. | accessdata.fda.gov |
| June 29, 2004 | 29495 | Not yet classified | Terminated | MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 | Skull pins, which fractured below device specifications during QC testing, were distributed. | accessdata.fda.gov |
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Updated September 3, 2019. 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.