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
1441–1464 of 18,110
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 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