Company
Integra LifeSciences Corp. (NeuroSciences)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
31recalls (13 in 12 months)
29recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRO | Dressing, Wound, Drug | 11 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 5 |
| FMF | Syringe, Piston | 4 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 4 |
| GWM | Device, Monitoring, Intracranial Pressure | 2 |
| GAD | Retractor | 1 |
| JXG | Shunt, Central Nervous System And Components | 1 |
| KTI | Bronchoscope Accessory | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | Integra LifeSciences Corp. (NeuroSciences) OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. Open, Classified |
GAD | None listed |
| May 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) 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 diverti Open, Classified |
JXG | K170599 |
| Apr 17, 2026 | Integra LifeSciences Corp. (NeuroSciences) CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system. Open, Classified |
LFL | K161882 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. Open, Classified |
KGN | K152721 |
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) 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 & Open, Classified |
FRO | K150985 |
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) 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 autoly Open, Classified |
FRO | K053095 |
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) 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 healin Open, Classified |
FRO | K101793 |
| Jan 8, 2026 | Integra LifeSciences Corp. (NeuroSciences) 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 I Open, Classified |
GWM | K173192 |
| Jan 8, 2026 | Integra LifeSciences Corp. (NeuroSciences) 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 Open, Classified |
GWM | K153347 |
| Nov 4, 2025 | Integra LifeSciences Corp. (NeuroSciences) TruDi Navigation System - Multi Instrument Adapter; -
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; Open, Classified |
PGW | K231862 |
| Nov 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator 9mm. Cranial Perforator. Open, Classified |
HBF | K183581 |
| Nov 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator 11mm. Cranial Perforator. Open, Classified |
HBF | K183581 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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-grad Open, Classified |
FRO | None listed |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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 Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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 w Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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 d Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Adhesive Hydrogel Sheet Dressing
Model/Catalog Number: 31720, 31740
Product Description: MEDIHONEY Adhesive Hydrogel Sheet Dressing with
Leptospermum Hone Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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 i Open, Classified |
FRO | K110546 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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 L Open, Classified |
FRO | K080315 |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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 Leptospermu Open, Classified |
FRO | K080315 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) 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. Open, Classified |
FMF | K082454 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator 8CM, Box of 1. Open, Classified |
FMF | K091315 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator, 15 CM, Box of 5. Open, Classified |
FMF | K091315 |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator, 8CM, Box of 5. Open, Classified |
FMF | K091315 |
| May 6, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit. Open, Classified |
HBF | K073336 |
| May 6, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator, 14mm. Cranial perforator. Open, Classified |
HBF | K183581 |
| May 6, 2025 | Integra LifeSciences Corp. (NeuroSciences) INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. Open, Classified |
KTI | K110218 |