ClearanceBrief
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

CodeDeviceRecords
FRODressing, Wound, Drug11
KGNWound Dressing With Animal-Derived Material(S)5
FMFSyringe, Piston4
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)4
GWMDevice, Monitoring, Intracranial Pressure2
GADRetractor1
JXGShunt, Central Nervous System And Components1
KTIBronchoscope Accessory1
LFLInstrument, Ultrasonic Surgical1
PGWEar, Nose, And Throat Stereotaxic Instrument1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 9, 2026Integra LifeSciences Corp. (NeuroSciences)
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Open, Classified
GADNone listed
May 13, 2026Integra 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
JXGK170599
Apr 17, 2026Integra LifeSciences Corp. (NeuroSciences)
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Open, Classified
LFLK161882
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Open, Classified
KGNK152721
Feb 13, 2026Integra 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
FROK150985
Feb 13, 2026Integra 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
FROK053095
Feb 13, 2026Integra 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
FROK101793
Jan 8, 2026Integra 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
GWMK173192
Jan 8, 2026Integra 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
GWMK153347
Nov 4, 2025Integra 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
PGWK231862
Nov 3, 2025Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Open, Classified
HBFK183581
Nov 3, 2025Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Open, Classified
HBFK183581
Sep 3, 2025Integra 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
FRONone listed
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK110546
Sep 3, 2025Integra 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
FROK080315
Sep 3, 2025Integra 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
FROK080315
Jun 20, 2025Integra 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
FMFK082454
Jun 20, 2025Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator 8CM, Box of 1.
Open, Classified
FMFK091315
Jun 20, 2025Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 15 CM, Box of 5.
Open, Classified
FMFK091315
Jun 20, 2025Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 8CM, Box of 5.
Open, Classified
FMFK091315
May 6, 2025Integra LifeSciences Corp. (NeuroSciences)
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Open, Classified
HBFK073336
May 6, 2025Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Open, Classified
HBFK183581
May 6, 2025Integra LifeSciences Corp. (NeuroSciences)
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Open, Classified
KTIK110218
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