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
625–648 of 18,182
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 CT 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