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
2161–2184 of 18,110
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 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