Integra LifeSciences Corporation
Plainsboro, NJ, US
INTEGRA LIFESCIENCES CORPORATION appears in FDA device records in Plainsboro, NJ. FDA records list 94 510(k) clearances between and , 497 PMA records and 3 registered establishments. As of , FDA records show 348 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Integra LifeSciences Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Integra Life Sci.enforcement report, recall
- Integra LifeSciences Corp. (NeuroSciences)enforcement report, recall
510(k) clearance history
Showing 50 of 94FDA records hold 94 510(k) clearances for Integra LifeSciences Corporation between 1999 and 2025. The busiest year on record is 2014, with 8. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 3 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 5 |
| 2007 | 7 |
| 2008 | 2 |
| 2009 | 4 |
| 2010 | 5 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 3 |
| 2014 | 8 |
| 2015 | 3 |
| 2016 | 6 |
| 2017 | 3 |
| 2018 | 7 |
| 2019 | 5 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | GWG | Substantially Equivalent | |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | KGN | Substantially Equivalent | |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | HRS | Substantially Equivalent | |
| K193346 | Codman Surgical Patties & Strips | HBA | Substantially Equivalent | |
| K201507 | Cadence Total Ankle System | HSN | Substantially Equivalent | |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K190588 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | JXG | Substantially Equivalent | |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K183581 | Codman Disposable Perforators | HBF | Substantially Equivalent | |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | GWM | Substantially Equivalent | |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | GEI | Substantially Equivalent | |
| K182265 | CodMan Certas Plus Programmable Valve | JXG | Substantially Equivalent | |
| K181639 | Panta 2 Arthrodesis Nail System | HSB | Substantially Equivalent | |
| K181902 | Codman Certas Plus Electronic Tool Kit | JXG | Substantially Equivalent | |
| K181999 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | |
| K173717 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | |
| K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K163457 | NeuraGen 3D Nerve Guide Matrix | JXI | Substantially Equivalent | |
| K163456 | DuraGen Secure Dural Regeneration Matrix | GXQ | Substantially Equivalent | |
| K160811 | CRW STEREOTACTIC SYSTEM | HAW | Substantially Equivalent | |
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | JXG | Substantially Equivalent | |
| K161189 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | |
| K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | JXG | Substantially Equivalent | |
| K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory | JXG | Substantially Equivalent | |
| K150682 | CUSA Excel+ | LFL | Substantially Equivalent | |
| 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 | |
| K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS | JXG | Substantially Equivalent | |
| K142238 | MAYFIELD Skull Clamp | HBL | Substantially Equivalent | |
| K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | |
| K141668 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | |
| K142414 | Miltex N-Tralig Intraligamentary Syringe | EJI | Substantially Equivalent | |
| K130557 | NEURAGEN 3D | JXI | Substantially Equivalent | |
| K134047 | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS | HCZ | Substantially Equivalent | |
| K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | JWJ | Substantially Equivalent | |
| K133754 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER | GWM | Substantially Equivalent | |
| K131446 | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES | DQR | Substantially Equivalent | |
| K131184 | INTEGRA LICOX PTO2 MONITOR | GWM | Substantially Equivalent | |
| K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP | HBL | Substantially Equivalent | |
| K123000 | INTEGRA TOTAL FOOT SYSTEMS | HRS | Substantially Equivalent | |
| K120012 | INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS | GCJ | Substantially Equivalent | |
| K120633 | MAYFIELD SKULL CLAMP | HBL | Substantially Equivalent | |
| K113104 | INTEGRA WOUND MATRIX (THIN) | KGN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1121308 | 1121308 | INTEGRA LIFESCIENCES CORPORATION | 105 and 109 MORGAN LANE, PLAINSBORO, NJ 08536 US | 2026 | |
| 3004608878 | 3004608878 | INTEGRA LIFESCIENCES CORPORATION | 4900 CHARLEMAR DR.,, CINCINNATI, OH 45227 US | 2026 | and 178 more, listed in full below |
| 3003418325 | 3003418325 | Integra LifeSciences Corporation | 1100 Campus Road, Princeton, NJ 08540 US | 2026 | and 423 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- EJRAgent, Polishing, Abrasive, Oral Cavity
- EJLBur, Dental
- EKJBurnisher, Operative
- DQRCannula, Catheter
- EKICarrier, Amalgam, Operative
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- EKHCarver, Dental Amalgam, Operative
- EIKCarver, Wax, Dental
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- EEFClamp, Rubber Dam
- DXCClamp, Vascular
- EKGCondenser, Amalgam And Foil, Operative
- EFNCotton, Roll
- DWPDilator, Vessel, Surgical
- EHJDisk, Abrasive
- DZADrill, Dental, Intraoral
- EHZEvacuator, Oral Cavity
- EKCExcavator, Dental, Operative
- EKBExplorer, Operative
- EFKForceps, Articulation Paper
- EFLForceps, Dressing, Dental
- EJGForceps, Rubber Dam Clamp
- BWBForceps, Tube Introduction
- EJEFrame, Rubber Dam
- EILGauge, Depth, Instrument, Dental
- EJBHandle, Instrument, Dental
- EFBHandpiece, Air-Powered, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EGZHolder, Film, X-Ray
- EKFInstrument, Contouring, Matrix, Operative
- DZPInstrument, Diamond, Dental
- EIYInstrument, Filling, Plastic, Dental
- DZNInstruments, Dental Hand
- DWSInstruments, Surgical, Cardiovascular
- EJZKnife, Margin Finishing, Operative
- CCWLaryngoscope, Rigid
- DYXLock, Wire, And Ligature, Intraoral
- EAXMirror, Mouth
- EFHPaper, Articulation
- EEAPlate, Base, Shellac
- EJYPliers, Operative
- EIXProbe, Periodontic
- ECSPusher, Band, Orthodontic
- CANRegulator, Pressure, Gas Cylinder
- EISRemover, Crown
- EIGRetractor, All Types
- EIRScissors, Collar And Crown
- EGNScissors, Surgical Tissue, Dental
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- EHMStrip, Polishing Agent
- CCXSupport, Patient Position
- EJISyringe, Cartridge
- EIDSyringe, Restorative And Impression Material
- BWNTable And Attachments, Operating-Room
- EHYTray, Impression, Preformed
- BTOTube, Tracheostomy (W/Wo Connector)
- ECBUnit, Syringe, Air And/Or Water
- EGDWax, Dental, Intraoral
- DZCWire, Orthodontic
Recall records
Showing 25 of 348| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2714-2026 | OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. | Class II | Open, Classified | |
| Z-2173-2026 | Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip. | Out-of-specification endotoxin result that did not meet the acceptance criteria. | Class II | Open, Classified | |
| Z-1820-2026 | Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. | Increased rate of out-of-specification endotoxin results. | Class II | Open, Classified | |
| Z-1819-2026 | Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. | Increased rate of out-of-specification endotoxin results. | Class II | Open, Classified | |
| Z-1818-2026 | Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. | Increased rate of out-of-specification endotoxin results. | Class II | Open, Classified | |
| Z-1817-2026 | Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. | Increased rate of out-of-specification endotoxin results. | Class II | Open, Classified | |
| Z-1816-2026 | Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. | Increased rate of out-of-specification endotoxin results. | Class II | Open, Classified | |
| Z-1828-2026 | CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system. | Software issue that renders the touch screen unresponsive. | Class II | Open, Classified | |
| Z-1365-2026 | Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions. | Potential packaging failures, which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1364-2026 | MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds | Potential packaging failures, which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1363-2026 | MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds. | Potential packaging failures, which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1037-2026 | Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only. | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. | Class II | Open, Classified | |
| Z-1036-2026 | Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only. | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. | Class II | Open, Classified | |
| Z-0420-2026 | TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; | It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy. | Class II | Open, Classified | |
| Z-0374-2026 | CODMAN Disposable Perforator 9mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. | Class I | Open, Classified | |
| Z-0373-2026 | CODMAN Disposable Perforator 11mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. | Class I | Open, Classified | |
| Z-2512-2025 | Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2511-2025 | Brand Name: MediHoney Product Name: MediHoney HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids and supports autolytic debridement, and allows for non-traumatic removal. The product is an occlusive dressing, and does not require a secondary dressing. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2510-2025 | Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2509-2025 | Brand Name: MediHoney Product Name: MediHoney Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 100%, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2508-2025 | Brand Name: MediHoney Product Name: MediHoney Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 100% Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2507-2025 | Brand Name: MediHoney Product Name: MediHoney HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2506-2025 | Brand Name: MediHoney Product Name: MediHoney Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-2505-2025 | Brand Name: MediHoney Product Name: MediHoney Paste Model/Catalog Number: 31505 Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Open, Classified | |
| Z-1961-2025 | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids. | Lack of sterility assurance. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain