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

Filters: Cardiovascular ×
18,182 results
2089–2112 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 23, 2019
Comet II Pressure Guidewire
K193279 · DXO
Boston Scientific Corporation
Cardiovascular · 26d
Cleared Dec 23, 2019
Arm Blood Pressure Monitor
K192023 · DXN
Truly Instrument Limited
Cardiovascular · 147d
Cleared CT Dec 20, 2019
Indigo Aspiration System
K192833 · QEW
Penumbra, Inc.
Cardiovascular · 79d
Cleared Dec 20, 2019
Carescape One
K190008 · MHX
Ge Healthcare
Cardiovascular · 352d
Cleared Dec 19, 2019
Halo One Thin-Walled Guiding Sheath
K192313 · DYB
C.R. Bard, Inc.
Cardiovascular · 115d
Cleared Dec 19, 2019
Hereaeus Poseidon Microcatheter
K191305 · KRA
Heraeus Medical Components, LLC
Cardiovascular · 219d
Cleared Dec 19, 2019
ZOLL Arrhythmia Management Sysyem
K190939 · MHX
Zoll Manufacturing Corporation
Cardiovascular · 253d
Cleared Dec 18, 2019
Electronic Stethoscope
K191667 · DQD
Hefei Mintti Medical Technology Co.,...
Cardiovascular · 180d
Cleared Dec 18, 2019
BioSticker System
K191614 · DRG
Biointellisense, Inc.
Cardiovascular · 183d
Cleared Dec 17, 2019
EV1000 Clinical Platform
K193179 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Dec 17, 2019
Bashir Plus Endovascular Catheter
K193071 · QEY
Thrombolex, Inc.
Cardiovascular · 43d
Cleared Dec 17, 2019
ILUMIEN System with AptiVue Software version D.3
K192267 · DQO
Abbott Medical
Cardiovascular · 118d
Cleared Dec 17, 2019
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K191758 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 169d
Cleared Dec 16, 2019
Physio Flex Annuloplasty Ring
K192762 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 77d
Cleared Dec 13, 2019
CrossTorq 14 Guidewire
K193194 · DQX
Scientia Cardio Access, LLC
Cardiovascular · 24d
Cleared Dec 13, 2019
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared Dec 13, 2019
C50 and C80 Multi-parameter Patient Monitor
K191106 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 232d
Cleared Dec 12, 2019
OptoMonitor
K192340 · DXO
Opsens, Inc.
Cardiovascular · 106d
Cleared Dec 12, 2019
Lumax Guiding Catheter
K191163 · DQY
Cook Incorporated
Cardiovascular · 225d
Cleared Dec 11, 2019
HI-TORQUE InfilTrac Guide Wire Family
K193126 · DQX
Abbott Vascular
Cardiovascular · 29d
Cleared Dec 11, 2019
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
K191880 · DRF
Innovative Health, LLC
Cardiovascular · 149d
Cleared Dec 09, 2019
FFRangio
K192442 · QEK
Cathworks, Ltd.
Cardiovascular · 94d
Cleared Dec 09, 2019
JETi Peripheral Thrombectomy System
K192439 · QEZ
Walk Vascular, LLC
Cardiovascular · 94d
Cleared Dec 08, 2019
T3 Platform software
K190273 · MWI
Etiometry, Inc.
Cardiovascular · 303d