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
457–480 of 18,110
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 Apr 04, 2025
JETi Hydrodynamic Thrombectomy System
K243549 · QEZ
Abbott Medical
Cardiovascular · 140d
Cleared 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 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