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
529–552 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 24, 2025
PeriCross™ Epicardial Access Kit
K243954 · DYB
Circa Scientific, Inc.
Cardiovascular · 122d
Cleared Apr 22, 2025
Aperta NSE PTA Balloon Dilatation Catheter
K243944 · PNO
Goodman Co., Ltd.
Cardiovascular · 123d
Cleared Apr 21, 2025
D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
K242254 · PNO
Dk Medical Technology Co., Ltd.
Cardiovascular · 264d
Cleared Apr 18, 2025
PeriBeam® Pericardial Membrane
K240775 · DXZ
Tamabio
Cardiovascular · 393d
Cleared Apr 17, 2025
FlowGuide (FG60F)
K242337 · DQY
Imds Operations B.V.
Cardiovascular · 253d
Cleared Apr 17, 2025
VitalRhythm
K242129 · DQK
Vitalconnect, Inc.
Cardiovascular · 269d
Cleared Apr 11, 2025
Cornaris Intravascular Imaging System (P80-E)
K242098 · NQQ
Shenzhen Vivolight Medical Device &...
Cardiovascular · 267d
Cleared Apr 08, 2025
Globalcare Blood Pressure Monitor (GUS610)
K250136 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 81d
Cleared Apr 04, 2025
Passeo-35 Xeo Peripheral Dilatation Catheter
K250706 · LIT
Biotronik, Inc.
Cardiovascular · 25d
Cleared Apr 04, 2025
LiquID .051 LP Guide Catheter Extension
K243691 · DQY
Seigla Medical, Inc.
Cardiovascular · 129d
Cleared CT Apr 04, 2025
JETi Hydrodynamic Thrombectomy System
K243549 · QEZ
Abbott Medical
Cardiovascular · 140d
Cleared CT Apr 04, 2025
WHOOP ECG (electrocardiogram) Feature (1.0)
K243236 · QDA
Whoop., Inc.
Cardiovascular · 176d
Cleared Apr 03, 2025
Masimo W1
K243305 · DPS
Masimo Corporation
Cardiovascular · 164d
Cleared Apr 02, 2025
SION blue PLUS
K243733 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 119d
Cleared Mar 27, 2025
SelectSite C304 Deflectable Catheter System (C304)
K250558 · DQY
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 27, 2025
Edwards eSheath Optima introducer set
K244046 · DYB
Edwards Lifesciences
Cardiovascular · 87d
Cleared Mar 27, 2025
Crossloop
K241962 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 267d
Cleared Mar 26, 2025
AC3™ Range™ Intra-Aortic Balloon Pump
K250542 · DSP
Arrow International, LLC
Cardiovascular · 30d
Cleared Mar 25, 2025
Aventus Thrombectomy System (IM-2100)
K250668 · QEW
Inquis Medical
Cardiovascular · 20d
Cleared CT Mar 25, 2025
Bolt Intravascular Lithotripsy (IVL) System
K250225 · PPN
Bolt Medical, Inc.
Cardiovascular · 57d
Cleared Mar 24, 2025
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S,...
K250013 · QEZ
Control Medical Technology, Inc. /...
Cardiovascular · 81d
Cleared Mar 24, 2025
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
K242893 · OBJ
Luma Vision Limited
Cardiovascular · 182d
Cleared Mar 21, 2025
FloTrac sensors
K242909 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 178d
Cleared Mar 21, 2025
Philips Holter Analysis System
K241890 · MLO
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 266d