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
649–672 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 01, 2024
VersaCross™ RF Wire
K242076 · DXF
Baylis Medical Company
Cardiovascular · 108d
Cleared Nov 01, 2024
Affera Integrated Mapping System
K241828 · DQK
Medtronic, Inc.
Cardiovascular · 130d
Cleared Nov 01, 2024
EP•XT™ Unidirectional Steerable Diagnostic Catheter
K240366 · DRF
Boston Scientific Corporation
Cardiovascular · 269d
Cleared Oct 31, 2024
Disposable Blood Pressure cuff
K242623 · DXQ
Shenzhen Medke Technology Co., Ltd.
Cardiovascular · 58d
Cleared Oct 31, 2024
SmartCardia 7L Platform (MCT)
K240653 · QYX
Smartcardia SA
Cardiovascular · 238d
Cleared Oct 30, 2024
Zio AT® device (A100A1001)
K240177 · DSI
iRhythm Technologies, Inc.
Cardiovascular · 281d
Cleared Oct 25, 2024
Pantera Pro
K242969 · LOX
Biotronik, Inc.
Cardiovascular · 29d
Cleared Oct 24, 2024
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
K241007 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 195d
Cleared Oct 22, 2024
Arm Type Blood Pressure Monitor (BPM82)
K242193 · DXN
Avita Corporation
Cardiovascular · 88d
Cleared Oct 22, 2024
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
K241478 · PNO
Brosmed Medical Co., Ltd.
Cardiovascular · 151d
Cleared Oct 21, 2024
Zio AT® device (A100A1001)
K240029 · QYX
iRhythm Technologies, Inc.
Cardiovascular · 291d
Cleared Oct 16, 2024
ONCOZENE Microspheres
K242794 · KRD
Varian Medical Systems, Inc.
Cardiovascular · 30d
Cleared Oct 16, 2024
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205,...
K241613 · DXN
Shenzhen Hbcare Technology Co.,Ltd
Cardiovascular · 133d
Cleared Oct 15, 2024
Artix™ MT
K241894 · QEW
Inari Medical, Inc.
Cardiovascular · 109d
Cleared Oct 11, 2024
Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)
K242133 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 81d
Cleared Oct 11, 2024
Reprocessed DECANAV™ Electrophysiology Catheter
K240826 · NLH
Sterilmed, Inc.
Cardiovascular · 199d
Cleared Oct 11, 2024
ARTAIRA Arterial Compression Device (AACD01)
K240499 · JOW
Airos Medical, Inc.
Cardiovascular · 234d
Not Cleared Oct 08, 2024
Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection...
DEN230076 · QXY
Omron Healthcare, Inc.
Cardiovascular · 330d
Cleared Oct 04, 2024
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113,...
K242721 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 24d
Cleared Oct 04, 2024
AuST Steerable Sheath
K242106 · DYB
CenterPoint Systems, LLC
Cardiovascular · 78d
Cleared Oct 04, 2024
UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF
K241746 · JOW
United Medical Resources, LLC
Cardiovascular · 108d
Cleared Oct 03, 2024
OBSIDIO™ Conformable Embolic
K242507 · KRD
Boston Scientific
Cardiovascular · 42d
Cleared Sep 30, 2024
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
K242276 · DQY
Vantis Vascular, Inc.
Cardiovascular · 60d
Cleared Sep 27, 2024
ClotTriever XL Catheter (41-102)
K242557 · QEW
Inari Medical, Inc.
Cardiovascular · 30d