Integra LifeSciences Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 29
- 510(k) Clearances
- 65
- Inspections
- 17
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2777-2016 | Class II | Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal | March 11, 2016 |
| Z-1084-2015 | Class II | The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: | December 19, 2014 |
| Z-1697-2014 | Class II | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 3 | March 28, 2014 |
| Z-1736-2013 | Class II | Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and tre | May 9, 2013 |
| Z-1296-2013 | Class II | OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dress | March 28, 2013 |
| Z-1302-2013 | Class II | Absorbable Collagen Sponge Provided As Intermediate to Another Company | March 28, 2013 |
| Z-1297-2013 | Class II | Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dres | March 28, 2013 |
| Z-1285-2013 | Class II | DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implan | March 28, 2013 |
| Z-1293-2013 | Class II | CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dre | March 28, 2013 |
| Z-1289-2013 | Class II | Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other | March 28, 2013 |
| Z-1295-2013 | Class II | HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dres | March 28, 2013 |
| Z-1294-2013 | Class II | HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dres | March 28, 2013 |
| Z-1283-2013 | Class II | Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an abs | March 28, 2013 |
| Z-1300-2013 | Class II | Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant | March 28, 2013 |
| Z-1298-2013 | Class II | OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implan | March 28, 2013 |
| Z-1290-2013 | Class II | Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (othe | March 28, 2013 |
| Z-1299-2013 | Class II | BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an | March 28, 2013 |
| Z-1287-2013 | Class II | NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinui | March 28, 2013 |
| Z-1291-2013 | Class II | Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dr | March 28, 2013 |
| Z-1292-2013 | Class II | CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dre | March 28, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | October 8, 2025 |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | April 9, 2025 |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | July 11, 2024 |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | July 11, 2023 |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | August 22, 2022 |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | July 15, 2022 |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | October 8, 2021 |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE S | July 27, 2021 |
| K193346 | Codman Surgical Patties & Strips | November 20, 2020 |
| K201507 | Cadence Total Ankle System | June 29, 2020 |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | June 23, 2020 |
| K190588 | Integra TITAN Reverse Shoulder System | December 2, 2019 |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage | October 11, 2019 |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | April 1, 2019 |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | December 7, 2018 |
| K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | November 27, 2018 |
| K181639 | Panta 2 Arthrodesis Nail System | November 2, 2018 |
| K181999 | Integra TITAN Reverse Shoulder System | October 12, 2018 |
| K173717 | Integra TITAN Reverse Shoulder System | June 21, 2018 |
| K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System | September 28, 2017 |