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
289–312 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 18, 2026
CARTO™ 3 EP Navigation System V9.0 with PIU Plus
K254085 · DQK
Biosense Webster, Inc.
Cardiovascular · 31d
Cleared Jan 17, 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
K251970 · LOX
Medtronic, Ireland
Cardiovascular · 205d
Cleared Jan 16, 2026
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
K251744 · DTM
Medtronic
Cardiovascular · 224d
Cleared Jan 16, 2026
OptoMonitor 3
K251367 · DXO
Opsens, Inc.
Cardiovascular · 260d
Cleared Jan 16, 2026
WAVE Clinical Platform (2.0.000)
K250135 · MWI
Baxter Healthcare Corp/ Excel Medical
Cardiovascular · 364d
Cleared Jan 15, 2026
Aventus Thrombectomy System
K253925 · QEZ
Inquis Medical
Cardiovascular · 38d
Cleared Jan 15, 2026
Bio-Medicus Life Support Catheter and Introducer
K251831 · QHW
Medtronic, Inc.
Cardiovascular · 216d
Cleared Jan 14, 2026
Concerto Versa™ Detachable Coil
K253511 · KRD
Medtronic, Inc.
Cardiovascular · 70d
Cleared Jan 12, 2026
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
K251307 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 259d
Cleared Jan 09, 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 29d
Cleared Jan 09, 2026
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
K253142 · DXN
Ningbo Ranor Medical Technology Co.,...
Cardiovascular · 106d
Cleared Jan 09, 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · DQX
Solo Pace, Inc.
Cardiovascular · 137d
Cleared Jan 09, 2026
Corvair Monza
K252589 · MHX
AliveCor, Inc.
Cardiovascular · 147d
Cleared Jan 08, 2026
Vision-MR™ Diagnostic Catheter
K252794 · DRF
Imricor Medical Systems, Inc.
Cardiovascular · 128d
Cleared Jan 07, 2026
Sangria™ Thrombectomy System
K251207 · QEW
Avantec Vascular Corporation
Cardiovascular · 264d
Cleared Jan 07, 2026
Reprocessed Agilis NxT Steerable Introducer
K250305 · PNE
Innovative Health
Cardiovascular · 338d
Cleared Dec 31, 2025
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC)
K243627 · DXC
Arc Trauma, LLC
Cardiovascular · 401d
Cleared Dec 22, 2025
AccurECG Analysis System (v2.0)
K252361 · DPS
Accurkardia, Inc.
Cardiovascular · 146d
Cleared Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 194d
Cleared Dec 22, 2025
Pression Wave PRO External Counter-Pulsation System
K250756 · DRN
Pression, Inc.
Cardiovascular · 285d
Cleared Dec 19, 2025
STAR Apollo™ Mapping System
K253733 · DQK
Rhythm AI, Ltd.
Cardiovascular · 25d
Cleared Dec 19, 2025
ProtekDilate Vascular Access Kit
K253616 · DRE
Sorin Group Italia S.R.L.
Cardiovascular · 31d
Cleared Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48),...
K253409 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Dec 19, 2025
eMurmur Heart AI
K252284 · DQD
Csd Labs
Cardiovascular · 150d