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
1513–1536 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 07, 2022
Agile Devices Angler Steerable, Deflectable Microcatheter
K211110 · KRA
Agile Devices, Inc.
Cardiovascular · 268d
Cleared Jan 06, 2022
Tigereye CTO-Crossing Catheter
K212468 · PDU
Avinger, Inc.
Cardiovascular · 153d
Cleared Jan 05, 2022
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K212115 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 182d
Cleared Dec 21, 2021
Progreat Lambda
K211078 · DQO
Terumo Clinical Supply Co., Ltd.
Cardiovascular · 253d
Cleared Dec 21, 2021
CardiaMend Pericardial and Epicardial Reconstruction Matrix
K210331 · PSQ
Helios Cardio, Inc.
Cardiovascular · 319d
Not Cleared Dec 21, 2021
CavaClear Laser Sheath
DEN210024 · QRJ
Spectranetics, Inc.
Cardiovascular · 179d
Cleared Dec 20, 2021
TR BAND Radial Compression Device
K213531 · DXC
Terumo Medical Corporation
Cardiovascular · 45d
Cleared Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K212776 · NLG
Innovative Health, LLC
Cardiovascular · 110d
Cleared Dec 17, 2021
Libby IAAA v1.0
K210931 · LLZ
Dyad Medical, Inc.
Cardiovascular · 263d
Cleared Dec 17, 2021
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood...
K203424 · DTZ
Qura S.R.L
Cardiovascular · 392d
Cleared Dec 17, 2021
Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
K200943 · FLL
Circa Scientific, LLC
Cardiovascular · 618d
Cleared Dec 15, 2021
Serranator PTA Serration Balloon Catheter
K213728 · PNO
Cagent Vascular, LLC
Cardiovascular · 19d
Cleared Dec 15, 2021
Chocolate PTA Balloon Catheter
K213631 · LIT
Medtronic, Inc.
Cardiovascular · 28d
Cleared Dec 15, 2021
Merit Siege Vascular Plug
K212817 · KRD
Merit Medical System, Inc.
Cardiovascular · 103d
Cleared Dec 15, 2021
Revolution Peripheral Atherectomy System
K212351 · MCW
Rex Medical, L.P.
Cardiovascular · 139d
Cleared Dec 14, 2021
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · QEY
Boston Scientific Corporation
Cardiovascular · 55d
Cleared Dec 10, 2021
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle...
K213638 · DYB
Argon Medical Devices
Cardiovascular · 22d
Cleared Dec 10, 2021
AMG PMP Infant
K202510 · DTZ
Eurosets S.R.L
Cardiovascular · 466d
Cleared Dec 09, 2021
AirStrip ONE Web Client with Alarm Communication Management (ACM)
K211949 · MSX
Airstrip Technologies, Inc.
Cardiovascular · 169d
Cleared Dec 09, 2021
Infinity Acute Care System (IACS) Monitoring Solution
K201764 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 528d
Cleared CT Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
K211898 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 170d
Cleared Dec 07, 2021
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS...
K213303 · IYO
Infraredx, Inc.
Cardiovascular · 64d
Cleared Dec 03, 2021
AHI System
K212219 · QNV
Fifth Eye, Inc.
Cardiovascular · 140d
Cleared Nov 30, 2021
KardiaMobile Card
K211668 · DXH
AliveCor, Inc.
Cardiovascular · 182d