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
1009–1032 of 18,182
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