FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
2017–2040 of 18,110
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 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