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
577–600 of 18,110
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