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
1177–1200 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 08, 2022
CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
K222038 · QNR
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 150d
Cleared Dec 07, 2022
ViewFlex Xtra ICE Catheter
K223077 · OBJ
Irvine Biomedical, A St. Jude Medical...
Cardiovascular · 68d
Cleared Dec 02, 2022
PageWriter TC35 Cardiograph
K221141 · DPS
Medizin Systeme Boblingen GmbH
Cardiovascular · 227d
Cleared Dec 02, 2022
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
K221113 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 231d
Cleared Dec 01, 2022
CentriMag Pre-connected Pack
K222297 · DTZ
Abbott
Cardiovascular · 122d
Cleared Dec 01, 2022
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D,...
K222125 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 136d
Cleared Dec 01, 2022
STAR Apollo Mapping System
K220786 · DQK
Rhythm Al, Ltd.
Cardiovascular · 259d
Cleared Nov 28, 2022
Aneroid Sphygmomanometer
K222652 · DXQ
Cardicare Company, Ltd.
Cardiovascular · 88d
Cleared Nov 23, 2022
EchoGo Heart Failure
K222463 · QUO
Ultromics Limited
Cardiovascular · 100d
Cleared Nov 22, 2022
GUS610 Blood pressure monitor
K222160 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 125d
Cleared Nov 22, 2022
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global...
K221704 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 162d
Cleared Nov 22, 2022
ANNE Pediatric
K221530 · DRG
Sibel, Inc.
Cardiovascular · 180d
Cleared Nov 21, 2022
Disposable Blood Pressure Cuff
K222420 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 102d
Cleared Nov 16, 2022
Heater-Cooler System 3T
K220635 · DWC
Livanova Deutschland, GmbH
Cardiovascular · 257d
Cleared Nov 15, 2022
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · CAC
Haemonetics Corporation
Cardiovascular · 154d
Cleared Nov 15, 2022
Cardio10
K220535 · DPS
Bionet Co., Ltd.
Cardiovascular · 264d
Cleared Nov 15, 2022
LifeSPARC System
K211830 · QNR
Cardiacassist, Inc.
Cardiovascular · 519d
Cleared Nov 14, 2022
Multiflex Steerable Sheath
K221655 · DYB
Vizaramed, Inc.
Cardiovascular · 160d
Cleared Nov 10, 2022
WOLF Thrombectomy™ SmartClaw Catheter
K221391 · QEW
Devoro Medical, Inc.
Cardiovascular · 181d
Cleared Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178 · DQY
Medtronic
Cardiovascular · 28d
Cleared Nov 07, 2022
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
K223127 · DQK
Edwards Lifeciences, LLC
Cardiovascular · 35d
Cleared Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve...
K222873 · DQY
Medtronic
Cardiovascular · 46d
Cleared Nov 07, 2022
Vericor Support Catheter
K222679 · KRA
Vascupatent Medical (Shenzhen) Co., Ltd.
Cardiovascular · 62d
Cleared Nov 07, 2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
K221833 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 137d