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
2569–2592 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 30, 2018
Mandril Wire Guide
K171997 · DQX
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 30, 2018
Performer Guiding Sheath
K171988 · DYB
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 29, 2018
CorPath GRX System
K180517 · DXX
Corindus, Inc.
Cardiovascular · 30d
Cleared Mar 29, 2018
NaviCross 0.018
K173799 · DQY
Terumo Corporation
Cardiovascular · 105d
Cleared Mar 29, 2018
Bloom2 Programmable Electrophysiology Stimulator
K173439 · JOQ
Fischer Medical
Cardiovascular · 146d
Cleared Mar 29, 2018
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo...
K172071 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 262d
Cleared Mar 28, 2018
PressureWire X
K180558 · DXO
St. Jude Medical (Now Part of Abbott...
Cardiovascular · 27d
Cleared Mar 28, 2018
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
K173591 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 127d
Cleared Mar 27, 2018
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood...
K170605 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 391d
Cleared Mar 23, 2018
CPRmeter 2 CPR Feedback Device
K173886 · LIX
Laerdal Medical AS
Cardiovascular · 92d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae Kit
K180456 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae and Introducer
K180453 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 21, 2018
WIRION
K180023 · NTE
Gardia Medical , Ltd.
Cardiovascular · 77d
Cleared Mar 19, 2018
OTW Takeru PTCA Balloon Dilatation Catheter
K172264 · LOX
KANEKA Corporation
Cardiovascular · 235d
Cleared Mar 19, 2018
Double Flexible Tip Wire Guides
K171912 · DQX
Cook Incorporated
Cardiovascular · 266d
Cleared Mar 16, 2018
MEMO 4D
K180411 · KRH
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Mar 16, 2018
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K171937 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 261d
Not Cleared Mar 16, 2018
Acumen Hypotension Prediction Index (HPI) Feature Software
DEN160044 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 536d
Cleared Mar 15, 2018
INSPIRE 6M Hollow Fiber Oxygenator
K180448 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Mar 14, 2018
Athena GTX Device Management Suite (ADMS) Software
K173203 · MSX
Athena Gtx
Cardiovascular · 163d
Cleared Mar 14, 2018
Cardiovascular Analzyer
K172431 · DSB
Physiowave, Inc.
Cardiovascular · 215d
Cleared Mar 09, 2018
Transjugular Liver Access Sets
K171820 · DYB
Cook Incorporated
Cardiovascular · 263d
Cleared Mar 09, 2018
Fixed Core Wire Guides
K171764 · DQX
Cook Incorporated
Cardiovascular · 268d
Cleared Mar 09, 2018
Wrist Type Blood Pressure Monitor
K162616 · DXN
Xuzhou Yongkang Electronic Science...
Cardiovascular · 535d