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Integra LifeSciences Corporation

FDA 510(k) & PMA Approved Devices — 32 products

Total Devices32
Categories15
Latest FDA decision2026-06-04
TypeNumberDevice NameCodeDateActions
PMA P810006 Agent, absorbable hemostatic, collagen basedLMF2026-06-04 View
PMA P850010 Agent, absorbable hemostatic, collagen basedLMF2026-06-04 View
PMA P040034 Sealant, duralNQR2026-02-27 View
PMA P080013 Sealant, duralNQR2026-02-27 View
510(k) K251162 CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL2025-10-08 View
510(k) K250752 AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG2025-04-09 View
510(k) K240493 CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL2024-07-11 View
510(k) K230427 CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2023-07-11 View
510(k) K221835 CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-08-22 View
510(k) K221763 CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-07-15 View
510(k) K210128 INTEGRA Wound Matrix (Macro-Channels)KGN2021-10-08 View
510(k) K210016 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS SystemHRS2021-07-27 View
510(k) K193346 Codman Surgical Patties & StripsHBA2020-11-20 View
510(k) K201507 Cadence Total Ankle SystemHSN2020-06-29 View
510(k) K200774 CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2020-06-23 View
510(k) K190588 Integra TITAN Reverse Shoulder SystemPHX2019-12-02 View
510(k) K191684 MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage SystemJXG2019-10-11 View
510(k) K190180 CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2019-04-01 View
510(k) K182809 CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2018-12-07 View
510(k) K182801 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting CableGEI2018-11-27 View

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Related Clinical Trials

NCT06453187A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg UlcersENROLLING_BY_INVITATIONNCT06857708The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®RECRUITING
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