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
217–240 of 18,110
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