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."
25–48 of 60
Search insights Median review: 34d Cleared: 100% Top manufacturer: AtriCure, Inc. Lead specialty: Cardiovascular
Cleared Feb 15, 2018
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM...
K180137 · GEH
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Jan 31, 2018
AtriClip FLEX-V
K180010 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Oct 25, 2017
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
K173031 · FZP
AtriCure, Inc.
General & Plastic Surgery · 27d
Cleared Oct 11, 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared May 19, 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded...
K163261 · FZP
AtriCure, Inc.
General & Plastic Surgery · 179d
Cleared Jan 03, 2017
Isolator Multifunctional Linear Pen
K163408 · OCL
AtriCure, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2016
cryoFORM cryoICE cryoablation probe
K152337 · GEH
AtriCure, Inc.
General & Plastic Surgery · 216d
Cleared Mar 18, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Jan 27, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
K153500 · FZP
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Jun 17, 2015
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K150996 · FZP
AtriCure, Inc.
General & Plastic Surgery · 63d
Cleared Nov 25, 2014
Atricure Cryo Module System
K142203 · GXH
AtriCure, Inc.
Neurology · 106d
Cleared Oct 29, 2014
cryoICE croablation probe
K142441 · GEH
AtriCure, Inc.
General & Plastic Surgery · 57d
Cleared Aug 28, 2014
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K142120 · FZP
AtriCure, Inc.
General & Plastic Surgery · 24d
Cleared Jan 24, 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared May 14, 2013
ATRICLIP GILLINOV-COSGROVE LAA CLIP
K131107 · FZP
AtriCure, Inc.
General & Plastic Surgery · 25d
Cleared Apr 05, 2013
ISOLATOR LINEAR PEN
K130521 · OCL
AtriCure, Inc.
Cardiovascular · 36d
Cleared Sep 26, 2012
COOLRAIL LINEAR PEN MODEL MCRI
K122611 · OCL
AtriCure, Inc.
Cardiovascular · 30d
Cleared Aug 29, 2012
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K122276 · FZP
AtriCure, Inc.
General & Plastic Surgery · 30d
Cleared Jun 06, 2012
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
K121507 · GEH
AtriCure, Inc.
General & Plastic Surgery · 16d
Cleared Aug 03, 2011
ATRICURE CRYO MODULE SYSTEM
K112072 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared Jun 09, 2011
ATRICURE DISSECTOR
K111020 · FTD
AtriCure, Inc.
General & Plastic Surgery · 58d
Cleared May 26, 2011
ATRICURE CRYO MODULE
K111042 · GEH
AtriCure, Inc.
General & Plastic Surgery · 41d
Cleared Apr 08, 2011
ATRICURE BIPOLAR SYSTEM
K110117 · OCL
AtriCure, Inc.
Cardiovascular · 80d
Cleared CT Nov 12, 2010
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS...
K101174 · OCL
AtriCure, Inc.
Cardiovascular · 199d