Company · US
Integra LifeSciences Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2025. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (0 in 12 months)
316recalls (0 in 12 months)
256recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 64 |
| JXG | Shunt, Central Nervous System And Components | 35 |
| GWM | Device, Monitoring, Intracranial Pressure | 34 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 29 |
| HBA | Neurosurgical Paddie | 24 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 23 |
| GXQ | Dura Substitute | 18 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 14 |
| HRS | Plate, Fixation, Bone | 10 |
| FST | Light, Surgical, Fiberoptic | 9 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 8 |
| JXI | Cuff, Nerve | 7 |
| LPG | Material, Dressing, Surgical, Polylactic Acid | 7 |
| MQV | Filler, Bone Void, Calcium Compound | 7 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 |
| HWC | Screw, Fixation, Bone | 6 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 5 |
| HAW | Neurological Stereotaxic Instrument | 5 |
| FCW | Light Source, Fiberoptic, Routine | 4 |
| FRO | Dressing, Wound, Drug | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2025 | K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Apr 9, 2025 | K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) Integra LifeSciences Corporation | GWG |
| Jul 11, 2024 | K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Jul 11, 2023 | K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Aug 22, 2022 | K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Jul 15, 2022 | K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Oct 8, 2021 | K210128 | INTEGRA Wound Matrix (Macro-Channels) Integra LifeSciences Corporation | KGN |
| Jul 27, 2021 | K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integr Integra LifeSciences Corporation | HRS |
| Nov 20, 2020 | K193346 | Codman Surgical Patties & Strips Integra LifeSciences Corporation | HBA |
| Jun 29, 2020 | K201507 | Cadence Total Ankle System Integra LifeSciences Corporation | HSN |
| Jun 23, 2020 | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Dec 2, 2019 | K190588 | Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation | PHX |
| Oct 11, 2019 | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System Integra LifeSciences Corporation | JXG |
| Apr 1, 2019 | K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Jan 20, 2019 | K183581 | Codman Disposable Perforators Integra Lifesciences Corp. | HBF |
| Jan 11, 2019 | K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable Integra Lifesciences Corp. | GWM |
| Dec 7, 2018 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Nov 27, 2018 | K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable Integra LifeSciences Corporation | GEI |
| Nov 20, 2018 | K182265 | CodMan Certas Plus Programmable Valve Integra Lifesciences Corp. | JXG |
| Nov 2, 2018 | K181639 | Panta 2 Arthrodesis Nail System Integra LifeSciences Corporation | HSB |
| Oct 25, 2018 | K181902 | Codman Certas Plus Electronic Tool Kit Integra Lifesciences Corp. | JXG |
| Oct 12, 2018 | K181999 | Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation | PHX |
| Jun 21, 2018 | K173717 | Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation | PHX |
| Sep 28, 2017 | K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Jan 6, 2017 | K163457 | NeuraGen 3D Nerve Guide Matrix Integra LifeSciences Corporation | JXI |
| Jan 6, 2017 | K163456 | DuraGen Secure Dural Regeneration Matrix Integra LifeSciences Corporation | GXQ |
| Dec 6, 2016 | K160811 | CRW STEREOTACTIC SYSTEM Integra LifeSciences Corporation | HAW |
| Oct 14, 2016 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation | LFL |
| Sep 22, 2016 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems Integra LifeSciences Corporation | JXG |
| Aug 25, 2016 | K161189 | Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation | PHX |
| Mar 14, 2016 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling Integra LifeSciences Corporation | JXG |
| Mar 4, 2016 | K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory Integra LifeSciences Corporation | JXG |
| Dec 18, 2015 | K150682 | CUSA Excel+ Integra Lifesciences Corp. | LFL |
| Apr 16, 2015 | K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Integra Lifesciences Corp. | HAE |
| Jan 6, 2015 | K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS Integra LifeSciences Corporation | JXG |
| Nov 24, 2014 | K142238 | MAYFIELD Skull Clamp Integra LifeSciences Corporation | HBL |
| Nov 6, 2014 | K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM Integra LifeSciences Corporation | LFL |
| Nov 6, 2014 | K141668 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM Integra LifeSciences Corporation | LFL |
| Oct 30, 2014 | K142414 | Miltex N-Tralig Intraligamentary Syringe Integra LifeSciences Corporation | EJI |
| Apr 24, 2014 | K130557 | NEURAGEN 3D Integra LifeSciences Corporation | JXI |
| Apr 11, 2014 | K134047 | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS Integra LifeSciences Corporation | HCZ |
| Mar 24, 2014 | K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM Integra LifeSciences Corporation | JWJ |
| Mar 6, 2014 | K133754 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER Integra LifeSciences Corporation | GWM |
| Oct 28, 2013 | K131446 | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES Integra LifeSciences Corporation | DQR |
| Aug 30, 2013 | K131184 | INTEGRA LICOX PTO2 MONITOR Integra Lifesciences Corp. | GWM |
| Apr 23, 2013 | K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP Integra LifeSciences Corporation | HBL |
| Dec 21, 2012 | K123000 | INTEGRA TOTAL FOOT SYSTEMS Integra LifeSciences Corporation | HRS |
| Sep 11, 2012 | K120012 | INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS Integra LifeSciences Corporation | GCJ |
| May 24, 2012 | K120633 | MAYFIELD SKULL CLAMP Integra LifeSciences Corporation | HBL |
| Feb 9, 2012 | K113104 | INTEGRA WOUND MATRIX (THIN) Integra LifeSciences Corporation | KGN |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2025 | Integra LifeSciences Corp. AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80 Open, Classified |
GWG | K201840 |
| Feb 12, 2025 | Integra LifeSciences Corp. Brand Name: MediHoney Gel
Product Name: MediHoney Wound & Burn Dressing Gel
Model/Catalog Number: 31815
Software Version: N/A
Product Description: MediHoney Gel with Active Leptospermum Honey is a moi Open, Classified |
FRO | K101793 |
| Jan 17, 2025 | Integra LifeSciences Corp. CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820.
Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydro Open, Classified |
JXG | None listed |
| Jan 17, 2025 | Integra LifeSciences Corp. CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL.
Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hy Open, Classified |
JXG | K223330 |
| Jan 17, 2025 | Integra LifeSciences Corp. CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810
Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydro Open, Classified |
JXG | None listed |
| Oct 30, 2024 | Integra LifeSciences Corp. Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US
Lot CT007694 Open, Classified |
GXQ | K152481 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 3-1/2X6
Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syst Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 3X6
Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 2X6
Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1-1/2X6
Model/Catalog Number: 801454.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1X6-200
Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 3/4X6
Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1/2X6
Model/Catalog Number: 801451.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1/4X6
Model/Catalog Number: 801450.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG STRP 1/8X6
Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syste Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 3X3
Model/Catalog Number: 801409.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1X3
Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X3
Model/Catalog Number: 801407.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X2
Model/Catalog Number: 801406.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X1-1/2
Model/Catalog Number: 801404.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervo Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1X1
Model/Catalog Number: 801403.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sys Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X1
Model/Catalog Number: 801402.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 3/4X3/4
Model/Catalog Number: 801401.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/2X1/2
Model/Catalog Number: 801400.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/4X1/4
Model/Catalog Number: 801399.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/4X3
Model/Catalog Number: 801398.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous s Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. SURG PAT XRAY 1/4X1-1/2
Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervo Open, Classified |
HBA | K193346 |
| Oct 29, 2024 | Integra LifeSciences Corp. MICR PATIE RND
Model/Catalog Number: 801396.
CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string a Open, Classified |
HBA | K193346 |
| Oct 10, 2024 | Integra LifeSciences Corp. MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) Open, Classified |
FRO | K080315 |
| Aug 5, 2024 | Integra LifeSciences Corp. TruDi NAV Suction, 0 Degrees;
Model/Catalog Number: TDNS000Z.
TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skul Open, Classified |
PGW | K180948 |
| Jul 11, 2024 | Integra LifeSciences Corp. AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. Open, Classified |
GWG | K232618 |
| Jun 21, 2024 | Integra LifeSciences Corp. CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue
Catalog Number: C2600*
*Note: you may see Open, Classified |
LFL | K141674 |
| Jun 12, 2024 | Integra LifeSciences Corp. CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospina Open, Classified |
JXG | K233448 |
| Jun 12, 2024 | Integra LifeSciences Corp. CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) a Open, Classified |
JXG | K233448 |
| Jun 12, 2024 | Integra LifeSciences Corp. CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other Open, Classified |
JXG | K233448 |
| May 20, 2024 | Integra LifeSciences Corp. Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure.
Catalog Number: INS5HND Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Dec 14, 2023 | Integra LifeSciences Corp. CereLink ICP Extension Cable (Extension Cable), Model No. 826845
Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part o Open, Classified |
GWM | K210993 K232890 |
| Dec 6, 2023 | Integra LifeSciences Corp. Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: 31004 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: HITHSP04 Open, Classified |
HBG | K961113 |
Newest 50 of 316.