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
985–1008 of 18,182
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