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
1153–1176 of 18,182
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