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
1081–1104 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 10, 2023
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
K222887 · DXN
Famidoc Technology Company Limited
Cardiovascular · 199d
Cleared Apr 07, 2023
Memo 3D Semirigid Annuloplasty Ring
K230318 · KRH
Corcym S.r.l.
Cardiovascular · 60d
Cleared Apr 06, 2023
Affinity Fusion™ Oxygenator System
K230640 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 06, 2023
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19,...
K223531 · MHX
GE Healthcare Finland Oy
Cardiovascular · 134d
Cleared Apr 06, 2023
RayFlow
K222023 · DQY
Hexacath
Cardiovascular · 269d
Cleared Apr 05, 2023
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor,...
K223630 · MXD
Medtronic, Inc.
Cardiovascular · 121d
Cleared Apr 05, 2023
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
K214009 · LIT
Dk Medical Technology Co., Ltd.
Cardiovascular · 516d
Cleared Apr 04, 2023
Reprocessed NRG Transseptal Needle
K213584 · QLZ
Innovative Health, LLC
Cardiovascular · 508d
Cleared Apr 03, 2023
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall...
K230028 · JOW
Cardinal Health200, LLC
Cardiovascular · 89d
Cleared Mar 31, 2023
Aspirex™ Thrombectomy System
K230356 · QEW
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Mar 31, 2023
ROVO Mechanical Thrombectomy Device
K220780 · QEW
2mg, Inc.
Cardiovascular · 379d
Cleared Mar 30, 2023
Maestro Microcatheter
K230636 · KRA
Merit Medical System, Inc.
Cardiovascular · 23d
Cleared Mar 29, 2023
Stethophone v1
K222871 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 188d
Cleared Mar 23, 2023
Triever16 Curve
K223419 · QEW
Inari Medical
Cardiovascular · 133d
Cleared Mar 23, 2023
AccurSound Electronic Stethoscope AS-101
K221805 · DQD
Heroic Faith International , Ltd.
Cardiovascular · 274d
Cleared Mar 22, 2023
Arise™ UHP Dilatation Catheter
K230191 · LIT
Creagh Medical, Ltd.
Cardiovascular · 57d
Cleared Mar 22, 2023
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular...
K223824 · DRA
Boston Scientific Corporation
Cardiovascular · 91d
Cleared Mar 22, 2023
CardioSTAT® ECG Test Solution
K223049 · DSH
Icentia, Inc.
Cardiovascular · 174d
Cleared Mar 17, 2023
Ablacath™ Mapping Catheter
K223666 · MTD
Ablacon, Inc.
Cardiovascular · 100d
Cleared Mar 17, 2023
InThrill Thrombectomy System
K223613 · QEW
Inari Medical, Inc.
Cardiovascular · 102d
Cleared Mar 17, 2023
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
K221782 · DRS
Merit Medical Pte. , Ltd.
Cardiovascular · 269d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 14, 2023
RevCore™ Thrombectomy Catheter.
K223609 · QEW
Inari Medical, Inc.
Cardiovascular · 102d
Cleared Mar 14, 2023
HeartBuds Electronic Stethoscope
K212906 · DQD
Heartbuds, LLC
Cardiovascular · 547d