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
937–960 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 01, 2023
FaceHeart Vitals Software Development Kit (FH vitals SDK)
K223622 · QME
Faceheart Corp.
Cardiovascular · 270d
Cleared Aug 30, 2023
AC3™ Series IABP
K232343 · DSP
Arrow International, LLC
Cardiovascular · 26d
Cleared Aug 30, 2023
LAA Exclusion System
K232295 · PZX
Syntheon, LLC
Cardiovascular · 29d
Cleared Aug 30, 2023
NIBPCuff
K231961 · DXQ
Shenzhen Sino-K Medical Technology...
Cardiovascular · 58d
Cleared Aug 30, 2023
S-Patch Ex Wearable ECG Patch
K231289 · DSH
Wellysis Corp.
Cardiovascular · 118d
Cleared Aug 30, 2023
SmartCardia 7L Platform
K231276 · DSI
Smartcardia SA
Cardiovascular · 120d
Cleared Aug 30, 2023
Ventrax™ Delivery System (VTR851)
K231246 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 121d
Cleared Aug 28, 2023
SoundBite® Crossing System XS Peripheral
K230159 · PDU
Soundbite Medical Solutions, Inc.
Cardiovascular · 221d
Cleared Aug 25, 2023
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
K230928 · OWQ
Vein 360, LLC
Cardiovascular · 144d
Cleared Aug 25, 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K230566 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 177d
Cleared Aug 25, 2023
Wrist Type Blood Pressure Monitor (W05,W1101L)
K230409 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 191d
Cleared Aug 25, 2023
VitalFlow™ Console
K230364 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 196d
Cleared Aug 25, 2023
VitalFlowTM Centrifugal Pump
K223898 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 240d
Cleared Aug 24, 2023
Essenz HLM, Essenz ILBM
K232291 · DTQ
Livanova Deutschland, GmbH
Cardiovascular · 23d
Cleared Aug 24, 2023
Current Health System
K231506 · MSX
Current Health , Ltd.
Cardiovascular · 92d
Cleared Aug 23, 2023
Withings Scan Monitor 2.0
K230812 · DPS
Withings
Cardiovascular · 152d
Cleared Aug 22, 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 22, 2023
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450...
K223574 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 265d
Cleared Aug 19, 2023
LUX-Dx II (M302)
K231328 · MXD
Boston Scientific Corp
Cardiovascular · 103d
Cleared Aug 18, 2023
Smart Wedge algorithm
K230579 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 169d
Cleared Aug 18, 2023
Sleepiz One+
K223163 · DRT
Sleepiz AG
Cardiovascular · 315d
Cleared Aug 11, 2023
Electronic Blood Pressure Monitor
K230642 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 156d
Cleared Aug 11, 2023
Otsuka Digital Feedback Device-RW
K223463 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 268d
Cleared Aug 10, 2023
EnSite™ X EP System
K231415 · DQK
Abbott Medical
Cardiovascular · 86d