Integra LifeSciences Corp.

FDA Regulatory Profile

Summary

Total Recalls
217 (5 Class I)
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1295-2025Class IIAURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. February 6, 2025
Z-1168-2025Class IIBrand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog NumberJanuary 10, 2025
Z-0977-2025Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable dDecember 16, 2024
Z-0978-2025Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. ImplantablDecember 16, 2024
Z-0979-2025Class IICODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable dDecember 16, 2024
Z-0262-2025Class IIDuraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694September 26, 2024
Z-0248-2025Class IISURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicateSeptember 20, 2024
Z-0244-2025Class IISURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indSeptember 20, 2024
Z-0255-2025Class IISURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated September 20, 2024
Z-0242-2025Class IISURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicSeptember 20, 2024
Z-0241-2025Class IISURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indSeptember 20, 2024
Z-0245-2025Class IISURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indSeptember 20, 2024
Z-0249-2025Class IISURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicatSeptember 20, 2024
Z-0236-2025Class IISURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are September 20, 2024
Z-0237-2025Class IISURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indSeptember 20, 2024
Z-0251-2025Class IISURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicateSeptember 20, 2024
Z-0252-2025Class IISURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicaSeptember 20, 2024
Z-0250-2025Class IISURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicatSeptember 20, 2024
Z-0238-2025Class IISURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are iSeptember 20, 2024
Z-0235-2025Class IIMICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips arSeptember 20, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K183581Codman Disposable PerforatorsJanuary 20, 2019
K183406CereLink ICP Monitor, CereLink ICP Extension CableJanuary 11, 2019
K182265CodMan Certas Plus Programmable ValveNovember 20, 2018
K181902Codman Certas Plus Electronic Tool KitOctober 25, 2018
K150682CUSA Excel+December 18, 2015
K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, InApril 16, 2015
K131184INTEGRA LICOX PTO2 MONITORAugust 30, 2013
K092227JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURSFebruary 17, 2010
K092395OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEMNovember 19, 2009
K081635INTEGRA MESHED BILAYER WOUND MATRIXDecember 4, 2008
K081401MAYFIELD MR/X-RAY SKULL CLAMPOctober 8, 2008
K072113INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301October 10, 2007
K072207DURAGEN XS DURAL REGENERATION MATRIXAugust 23, 2007
K063124INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPSJanuary 19, 2007
K053244LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KITMay 10, 2006
K051440MAYFIELD INFINITY SKULL CLAMPSeptember 20, 2005
K050319MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104March 31, 2005
K050492INTEGRA BONE FIXATION SYSTEMMarch 14, 2005
K043427DURAGEN II DURAL REGENERATION MATRIXJanuary 12, 2005
K041620NEURA WRAP NERVE PROTECTORJuly 16, 2004