Integra Lifesciences Corp.
Integra Lifesciences Corp. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2019, with 217 FDA device recalls on record.
Top product codes for Integra Lifesciences Corp.
FDA recalls by Integra Lifesciences Corp.
10 most recent of 217- Z-1295-2025 — 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
- Z-1168-2025 — 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 moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. 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. Component: No
- Z-0977-2025 — 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 hydrocephalus.
- Z-0978-2025 — 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 hydrocephalus.
- Z-0979-2025 — 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 hydrocephalus.
- Z-0262-2025 — Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
- Z-0238-2025 — 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 system, during surgery.
- Z-0255-2025 — 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, during surgery.
- Z-0237-2025 — 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 system, during surgery.
- Z-0252-2025 — 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 system, during surgery.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Integra Lifesciences Corp.
- K183581 — Codman Disposable Perforators
- K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable
- K182265 — CodMan Certas Plus Programmable Valve
- K181902 — Codman Certas Plus Electronic Tool Kit
- K150682 — CUSA Excel+
- 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
- K131184 — INTEGRA LICOX PTO2 MONITOR
- K092227 — JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
- K092395 — OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
- K081635 — INTEGRA MESHED BILAYER WOUND MATRIX
- K081401 — MAYFIELD MR/X-RAY SKULL CLAMP
- K072113 — INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
- K072207 — DURAGEN XS DURAL REGENERATION MATRIX
- K063124 — INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
- K053244 — LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
- K051440 — MAYFIELD INFINITY SKULL CLAMP
- K050319 — MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
- K050492 — INTEGRA BONE FIXATION SYSTEM
- K043427 — DURAGEN II DURAL REGENERATION MATRIX
- K041620 — NEURA WRAP NERVE PROTECTOR
- K032693 — DURAGEN PLUS DURAL GRAFT MATRIX
- K030289 — HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
- K022127 — AVAGEN WOUND DRESSING
- K021792 — BILAYER MATRIX WOUND DRESSING
- K003229 — BIOPATCH ANTIMICROBIAL DRESSING
- K011168 — NEUROGEN NERVE GUIDE
- K992216 — BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
- K982180 — DURAGEN DURAL GRAFT MATRIX
- K990086 — HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.