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
913–936 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 27, 2023
Micro Ace™ Advanced Micro Access System
K232609 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Sep 27, 2023
Thinline Sheath Introducer
K232260 · DYB
Inneuroco, Inc.
Cardiovascular · 58d
Cleared Sep 27, 2023
FreedomFlow Orbital Circumferential Atherectomy System
K231538 · MCW
Cardio Flow Inc.,
Cardiovascular · 120d
Cleared Sep 27, 2023
Talon Transseptal Sheath
K231108 · DYB
Inari Medical, Inc.
Cardiovascular · 161d
Cleared Sep 26, 2023
AVVIGO'+ Multi-Modality Guidance System
K230884 · DQK
Boston Scientific Corporation
Cardiovascular · 180d
Not Cleared Sep 26, 2023
VasQ
DEN220026 · QVQ
Laminate Medical Technologies , Ltd.
Cardiovascular · 515d
Cleared Sep 25, 2023
Holter ECG and ABP System
K230184 · DSH
Edan Instruments, Inc.
Cardiovascular · 245d
Cleared Sep 21, 2023
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere...
K231248 · DYG
Edwards Lifesciencess, LLC
Cardiovascular · 143d
Cleared Sep 18, 2023
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201,...
K231367 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 130d
Cleared Sep 15, 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 28d
Cleared Sep 15, 2023
Sensis Vibe (VD15)
K223812 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 269d
Not Cleared Sep 13, 2023
ensoETM
DEN230021 · QXV
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 167d
Cleared Sep 11, 2023
Change Healthcare Cardiology Hemodynamics™
K230881 · MWI
Change Healthcare Israel , Ltd.
Cardiovascular · 165d
Cleared Sep 08, 2023
CorVista® System
K232686 · QXX
Corvista Health, Inc.
Cardiovascular · 7d
Cleared Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with...
K232386 · NQQ
Abbott Medical
Cardiovascular · 30d
Cleared Sep 08, 2023
Cleerly ISCHEMIA
K231335 · QXZ
Cleerly, Inc.
Cardiovascular · 123d
Cleared Sep 07, 2023
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K232443 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 24d
Cleared Sep 07, 2023
Pounce™ Sheath
K231828 · DYB
Surmodics,Inc.
Cardiovascular · 78d
Cleared Sep 07, 2023
Digital Blood Pressure Monitor WBP Series
K231542 · DXN
Weony (Shenzhen) Technology Co., Ltd.
Cardiovascular · 100d
Cleared Sep 07, 2023
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
K231207 · DQK
Biosense Webster, Inc.
Cardiovascular · 133d
Cleared Sep 07, 2023
Arm Blood Pressure Monitor
K230649 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 182d
Cleared Sep 07, 2023
AeroDVx Arm System
K222823 · JOW
Sun Scientific, Inc.
Cardiovascular · 353d
Not Cleared Sep 06, 2023
esolution
DEN230006 · QXU
S4 Medical Corp.
Cardiovascular · 225d
Cleared Sep 05, 2023
ICHOR 14F Embolectomy System
K230743 · QEW
Ichor
Cardiovascular · 173d