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
2233–2256 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 10, 2019
physIQ Heart Rhythm and Respiratory Module
K183322 · DPS
Physiq, Inc.
Cardiovascular · 222d
Cleared Jul 09, 2019
LifeSPARC Pump, LifeSPARC Controller
K183623 · KFM
Cardiacassist, Inc.
Cardiovascular · 195d
Cleared Jul 05, 2019
AngioVac C20, AngioVac C180
K190594 · DWF
AngioDynamics, Inc.
Cardiovascular · 120d
Cleared Jul 05, 2019
BIOMONITOR III, Remote Assistant III
K190548 · MXD
Biotronik, Inc.
Cardiovascular · 122d
Cleared Jul 03, 2019
Arm-type Electronic Blood Pressure Monitor
K183058 · DXN
Shenzhen Bsx Technology Electronics...
Cardiovascular · 243d
Cleared Jul 02, 2019
iLab Polaris Multi-Modality Guidance System
K191008 · DQK
Boston Scientific Corporation
Cardiovascular · 77d
Cleared Jul 02, 2019
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral...
K190634 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 112d
Cleared Jul 02, 2019
Site Seal SV
K190351 · DXC
Ensite Vascular
Cardiovascular · 138d
Cleared Jul 01, 2019
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K190980 · DRF
Innovative Health, LLC
Cardiovascular · 77d
Cleared Jul 01, 2019
ASAHI Silverway
K183062 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Jun 28, 2019
Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3,...
K190475 · DQY
Centerpoint Systems
Cardiovascular · 121d
Cleared Jun 28, 2019
UltraFlex IAB
K190101 · DSP
Arrow International, Inc.
Cardiovascular · 157d
Cleared Jun 27, 2019
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K191175 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 57d
Cleared Jun 25, 2019
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K190785 · NLG
Innovative Health, LLC
Cardiovascular · 90d
Cleared Jun 24, 2019
Oscillometric Blood Pressure Monitor
K190927 · DXN
Rudolf Riester GmbH
Cardiovascular · 76d
Cleared Jun 24, 2019
Intra-Operative Positioning System
K190106 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 153d
Cleared Jun 22, 2019
ASAHI SASUKE
K182844 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 256d
Cleared Jun 21, 2019
FloPatch (FP110)
K191388 · DPW
Flosonics Medical (R/A 1929803...
Cardiovascular · 28d
Cleared Jun 21, 2019
The ClearSight finger cuffs
K190130 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 144d
Cleared Jun 18, 2019
Aneroid Type Blood Pressure Kit
K191209 · DXQ
Dongguan Mars Medical Products Co., Ltd.
Cardiovascular · 43d
Cleared Jun 18, 2019
Torpedo Gelatin Foam
K183578 · KRD
Biosphere Medical, S.A.
Cardiovascular · 179d
Cleared Jun 17, 2019
FlowTriever Retrieval/Aspiration System
K191368 · QEW
Inari Medical
Cardiovascular · 26d
Cleared CT Jun 14, 2019
VIVO
K183195 · DQK
Catheter Precision, Inc.
Cardiovascular · 207d
Cleared Jun 13, 2019
Edwards Pressure Cable
K191089 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 50d