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
553–576 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 05, 2024
Magnetic Localization Patch Kit (AFR-00021)
K243435 · DQK
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 04, 2024
SSPC NXT Delivery Catheter
K243180 · DQY
CenterPoint Systems, LLC
Cardiovascular · 65d
Cleared Dec 04, 2024
DeepRhythmAI
K241197 · DQK
Medicalgorithmics S.A.
Cardiovascular · 218d
Cleared Nov 29, 2024
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
K242225 · NLH
Surgical Instrument Service and...
Cardiovascular · 123d
Cleared Nov 26, 2024
Cross Wise™ Multi-Use RF Adapter Cable
K243193 · DXF
Circa Scientific, Inc.
Cardiovascular · 57d
Cleared Nov 26, 2024
Arm Blood Pressure Monitor (model: BPM-A7VL)
K243118 · DXN
Shenzhen Imdk Medical Technology Co.,...
Cardiovascular · 57d
Cleared Nov 26, 2024
R2P Radifocus Glidewire Advantage
K240818 · DQX
Terumo Corporation
Cardiovascular · 246d
Cleared Nov 25, 2024
AccurSound Electronic Stethoscope (AS101)
K242971 · DQD
Heroic Faith International , Ltd.
Cardiovascular · 60d
Cleared Nov 25, 2024
Versus™ Catheter (VS110-8B)
K241851 · QEY
Liquet Medical, Inc.
Cardiovascular · 151d
Cleared Nov 20, 2024
Element Vascular Access System
K242520 · DYB
Penumbra, Inc.
Cardiovascular · 89d
Cleared Nov 18, 2024
MICRO Arterial Filters
K242092 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 124d
Cleared Nov 18, 2024
Informed Vital Core Application (IVC App)
K241633 · QME
Mindset Medical, Inc.
Cardiovascular · 165d
Cleared Nov 15, 2024
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K242419 · LIT
Creagh Medical Ltd. Dba Surmodics, Inc.
Cardiovascular · 92d
Cleared Nov 15, 2024
Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ...
K241224 · NLH
Surgical Instrument Service and...
Cardiovascular · 197d
Cleared Nov 15, 2024
Gelsoft™ Plus Vascular Prostheses
K241070 · DSY
Vascutek, Ltd.
Cardiovascular · 210d
Cleared Nov 15, 2024
EchoGo Amyloidosis (1.0)
K240860 · SDJ
Ultromics Limited
Cardiovascular · 232d
Cleared Nov 14, 2024
Hinscope
K241397 · MSX
Hinlab Sas
Cardiovascular · 182d
Cleared Nov 12, 2024
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018 · DRG
Lifesignals, Inc.
Cardiovascular · 125d
Cleared Nov 09, 2024
esolution® Esophageal Retractor
K243233 · QXU
S4 Medical Corp.
Cardiovascular · 31d
Cleared Nov 08, 2024
Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080,...
K242756 · DYB
Pulnovo Medical (Wuxi) Co., Ltd.
Cardiovascular · 57d
Cleared Nov 08, 2024
Frontier X Plus
K240794 · MLO
Fourth Frontier Technologies Pvt, Ltd.
Cardiovascular · 231d
Cleared Nov 06, 2024
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K240997 · DQX
Abbott Medical
Cardiovascular · 209d
Cleared Nov 05, 2024
FreedomFlow™ Orbital Circumferential Atherectomy System
K242947 · MCW
Cardio Flow Inc.,
Cardiovascular · 41d
Cleared Nov 04, 2024
SonoStik Guide Wire Introducer
K243061 · DYB
Sonostik, LLC
Cardiovascular · 38d