Integra LifeSciences Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 217 (5 Class I)
- 510(k) Clearances
- 29
- Inspections
- 0
- Compliance Actions
- 0
Known Names
integra lifesciences corporation, integra lifesciences
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1295-2025 | Class II | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. | February 6, 2025 |
| Z-1168-2025 | Class II | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number | January 10, 2025 |
| Z-0977-2025 | Class II | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable d | December 16, 2024 |
| Z-0978-2025 | Class II | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantabl | December 16, 2024 |
| Z-0979-2025 | Class II | CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable d | December 16, 2024 |
| Z-0262-2025 | Class II | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 | September 26, 2024 |
| Z-0248-2025 | Class II | SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicate | September 20, 2024 |
| Z-0244-2025 | Class II | SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are ind | September 20, 2024 |
| Z-0255-2025 | Class II | SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated | September 20, 2024 |
| Z-0242-2025 | Class II | SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indic | September 20, 2024 |
| Z-0241-2025 | Class II | SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are ind | September 20, 2024 |
| Z-0245-2025 | Class II | SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are ind | September 20, 2024 |
| Z-0249-2025 | Class II | SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicat | September 20, 2024 |
| Z-0236-2025 | Class II | SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are | September 20, 2024 |
| Z-0237-2025 | Class II | SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are ind | September 20, 2024 |
| Z-0251-2025 | Class II | SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicate | September 20, 2024 |
| Z-0252-2025 | Class II | SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indica | September 20, 2024 |
| Z-0250-2025 | Class II | SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicat | September 20, 2024 |
| Z-0238-2025 | Class II | SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are i | September 20, 2024 |
| Z-0235-2025 | Class II | MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips ar | September 20, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183581 | Codman Disposable Perforators | January 20, 2019 |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | January 11, 2019 |
| K182265 | CodMan Certas Plus Programmable Valve | November 20, 2018 |
| K181902 | Codman Certas Plus Electronic Tool Kit | October 25, 2018 |
| K150682 | CUSA Excel+ | December 18, 2015 |
| K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, In | April 16, 2015 |
| K131184 | INTEGRA LICOX PTO2 MONITOR | August 30, 2013 |
| K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | February 17, 2010 |
| K092395 | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM | November 19, 2009 |
| K081635 | INTEGRA MESHED BILAYER WOUND MATRIX | December 4, 2008 |
| K081401 | MAYFIELD MR/X-RAY SKULL CLAMP | October 8, 2008 |
| K072113 | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 | October 10, 2007 |
| K072207 | DURAGEN XS DURAL REGENERATION MATRIX | August 23, 2007 |
| K063124 | INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS | January 19, 2007 |
| K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | May 10, 2006 |
| K051440 | MAYFIELD INFINITY SKULL CLAMP | September 20, 2005 |
| K050319 | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 | March 31, 2005 |
| K050492 | INTEGRA BONE FIXATION SYSTEM | March 14, 2005 |
| K043427 | DURAGEN II DURAL REGENERATION MATRIX | January 12, 2005 |
| K041620 | NEURA WRAP NERVE PROTECTOR | July 16, 2004 |