Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

74 results for "Integra LifeSciences Corporation"
1–24 of 74
Search insights Median review: 80d Cleared: 100% Top manufacturer: Integra LifeSciences Corporation Lead specialty: Neurology
Cleared Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 176d
Cleared Apr 09, 2025
AURORA® Surgiscope® System (ASX15/60)
K250752 · GWG
Integra LifeSciences Corporation
Neurology · 28d
Cleared Jul 11, 2024
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493 · LFL
Integra LifeSciences Corporation
Obstetrics & Gynecology · 142d
Cleared Jul 11, 2023
CUSA Clarity Ultrasonic Surgical Aspirator System
K230427 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 144d
Cleared Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221835 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 60d
Cleared Jul 15, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221763 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 28d
Cleared Oct 08, 2021
INTEGRA Wound Matrix (Macro-Channels)
K210128 · KGN
Integra LifeSciences Corporation
General & Plastic Surgery · 262d
Cleared Jul 27, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot...
K210016 · HRS
Integra LifeSciences Corporation
Orthopedic · 204d
Cleared Nov 20, 2020
Codman Surgical Patties & Strips
K193346 · HBA
Integra LifeSciences Corporation
Neurology · 353d
Cleared Jun 29, 2020
Cadence Total Ankle System
K201507 · HSN
Integra LifeSciences Corporation
Orthopedic · 24d
Cleared Jun 23, 2020
CUSA Clarity Ultrasonic Surgical Aspirator System
K200774 · LFL
Integra LifeSciences Corporation
Neurology · 90d
Cleared Dec 02, 2019
Integra TITAN Reverse Shoulder System
K190588 · PHX
Integra LifeSciences Corporation
Orthopedic · 270d
Cleared Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume...
K191684 · JXG
Integra LifeSciences Corporation
Neurology · 109d
Cleared Apr 01, 2019
CUSA Clarity Ultrasonic Surgical Aspirator System
K190180 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 59d
Cleared Dec 18, 2018
Integra Salto Total Ankle System
K182878 · HSN
Ascension Orthopedics
Orthopedic · 64d
Cleared Dec 07, 2018
CUSA Clarity Ultrasonic Surgical Aspirator System
K182809 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 65d
Cleared Nov 27, 2018
Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator...
K182801 · GEI
Integra LifeSciences Corporation
General & Plastic Surgery · 56d
Cleared Nov 02, 2018
Panta 2 Arthrodesis Nail System
K181639 · HSB
Integra LifeSciences Corporation
Orthopedic · 134d
Cleared Oct 12, 2018
Integra TITAN Reverse Shoulder System
K181999 · PHX
Integra LifeSciences Corporation
Orthopedic · 78d
Cleared Jun 21, 2018
Integra TITAN Reverse Shoulder System
K173717 · PHX
Integra LifeSciences Corporation
Orthopedic · 198d
Cleared Sep 28, 2017
CUSA Excel+ Ultrasonic Surgical Aspirator System
K172595 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 30d
Cleared Jun 07, 2017
SurgiMend PRS Meshed, Revize-X
K171357 · OXH
Integra Lifesciences Corporation...
General & Plastic Surgery · 29d
Cleared Feb 16, 2017
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
K162965 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 115d
Cleared Jan 06, 2017
NeuraGen 3D Nerve Guide Matrix
K163457 · JXI
Integra LifeSciences Corporation
Neurology · 28d