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
1249–1272 of 18,182
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 CT 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