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

60 results for "AtriCure, Inc."
1–24 of 60
Search insights Median review: 34d Cleared: 100% Top manufacturer: AtriCure, Inc. Lead specialty: Cardiovascular
Cleared Oct 21, 2026
ACHM30 AtriClip FLEX-Mini LAA Exclusion System
K263319 · PZX
AtriCure, Inc.
Cardiovascular · 30d
Cleared Jul 24, 2025
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056 · OCL
AtriCure, Inc.
Cardiovascular · 23d
Cleared Apr 10, 2025
cryoICE cryoXT cryoablation probe (cryoXT)
K250371 · GXH
AtriCure, Inc.
Neurology · 59d
Cleared Jan 15, 2025
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · PZX
AtriCure, Inc.
Cardiovascular · 30d
Cleared Oct 29, 2024
AtriCure cryoICE BOX (ACM)
K243157 · GXH
AtriCure, Inc.
Neurology · 29d
Cleared Aug 27, 2024
Isolator Synergy EnCapture Ablation System (EMH)
K234151 · OCL
AtriCure, Inc.
Cardiovascular · 242d
Cleared Jul 29, 2024
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · PZX
AtriCure, Inc.
Cardiovascular · 214d
Cleared Feb 13, 2024
EPi-Ease Epicardial Access Device (EAS)
K233959 · DYB
AtriCure, Inc.
Cardiovascular · 60d
Cleared Nov 02, 2023
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407 · PZX
AtriCure, Inc.
Cardiovascular · 28d
Cleared Oct 26, 2023
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP)
K233170 · GXH
AtriCure, Inc.
Neurology · 29d
Cleared Dec 30, 2022
Isolator® Linear Pen (MLP1)
K221358 · OCL
AtriCure, Inc.
Cardiovascular · 233d
Cleared Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · OCL
AtriCure, Inc.
Cardiovascular · 157d
Cleared May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared Mar 03, 2021
AtriClip LAA Exclusion System
K210293 · PZX
AtriCure, Inc.
Cardiovascular · 29d
Cleared Dec 23, 2020
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE...
K200697 · GXH
AtriCure, Inc.
Neurology · 281d
Cleared Dec 13, 2019
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared Nov 04, 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
K192125 · OCL
AtriCure, Inc.
Cardiovascular · 90d
Cleared Aug 21, 2019
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip...
K191413 · PZX
AtriCure, Inc.
Cardiovascular · 85d
Cleared Jul 24, 2019
Coolrail Linear Pen
K190587 · OCL
AtriCure, Inc.
Cardiovascular · 139d
Cleared Feb 25, 2019
COBRA Fusion Ablation System
K190151 · OCL
AtriCure, Inc.
Cardiovascular · 26d
Cleared Dec 04, 2018
Coolrail Linear Pen
K183065 · OCL
AtriCure, Inc.
Cardiovascular · 29d
Cleared Nov 09, 2018
AtriCure cryoICE cryoSPHERE cryoablation probe
K182565 · GXH
AtriCure, Inc.
Neurology · 52d
Cleared Jun 28, 2018
ArtiClip LAA Exclusion System
K181474 · PZX
AtriCure, Inc.
Cardiovascular · 24d
Cleared Feb 15, 2018
AtriCure cryoICE cryo-ablation probe (CRYO2)
K180138 · GXH
AtriCure, Inc.
Neurology · 29d