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
409–432 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 13, 2025
Excipio LV Prime Thrombectomy Device
K251485 · QEW
Contego Medical, Inc.
Cardiovascular · 30d
Cleared Jun 13, 2025
Aventus Thrombectomy System
K251189 · QEW
Inquis Medical
Cardiovascular · 57d
Cleared Jun 13, 2025
Medtronic Stedi Extra Support Guidewire
K250075 · DQX
Medtronic, Inc.
Cardiovascular · 154d
Cleared Jun 11, 2025
Liberant Thrombectomy System
K250787 · QEW
Medtronic, Ireland
Cardiovascular · 89d
Cleared Jun 06, 2025
Empatica Health Monitoring Platform
K242737 · MWI
Empatica S.R.L.
Cardiovascular · 268d
Cleared Jun 05, 2025
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic...
K250545 · OWQ
Surgical Instrument Service and...
Cardiovascular · 100d
Cleared Jun 05, 2025
Central Station
K242750 · MSX
Nihon Kohden Digital Health...
Cardiovascular · 266d
Cleared Jun 04, 2025
PhysCade System
K250749 · DQK
Physcade, Inc.
Cardiovascular · 84d
Cleared Jun 04, 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
K250259 · DRG
The ScottCare Corporation
Cardiovascular · 127d
Cleared Jun 03, 2025
Globe Introducer (601-01001)
K250529 · DRA
Kardium, Inc.
Cardiovascular · 99d
Cleared Jun 02, 2025
GORE® Tri-Lobe Balloon Catheter
K250410 · DQY
W.L. Gore & Associates, Inc.
Cardiovascular · 109d
Cleared May 31, 2025
LimFlow ARC
K251376 · PDU
LimFlow, Inc.
Cardiovascular · 29d
Cleared May 30, 2025
Prestige Coil System (Prestige Packing Line Extension)
K251383 · KRD
Balt USA, LLC
Cardiovascular · 28d
Cleared May 30, 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
K250150 · DTR
Sorin Group Italia S.R.L.
Cardiovascular · 129d
Cleared May 30, 2025
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078 · QME
Mindset Medical, Inc.
Cardiovascular · 137d
Cleared May 29, 2025
VersaCross Connect™ Transseptal Dilator
K251325 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 30d
Cleared May 29, 2025
Radius VSM and Accessories
K250757 · MHX
Masimo Corporation
Cardiovascular · 78d
Cleared May 29, 2025
PM2+ System and SmartPICC Stylet
K243484 · LJS
Piccolo Medical, Inc.
Cardiovascular · 202d
Not Cleared May 29, 2025
Spur Peripheral Retrievable Stent System
DEN240048 · SEU
Reflow Medical, Inc.
Cardiovascular · 251d
Cleared May 28, 2025
OptiMap™ System
K251344 · DQK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared May 27, 2025
DeepRhythmAI
K250932 · DQK
Medicalgorithmics S.A.
Cardiovascular · 60d
Cleared May 23, 2025
ViewFlex™ Xtra ICE Catheter
K251211 · OBJ
Abbott Medical
Cardiovascular · 35d
Cleared May 21, 2025
InVision Precision Cardiac Amyloid
K243866 · SDJ
Invision Medical Technology Corporation
Cardiovascular · 155d
Cleared May 20, 2025
ViewFlex™ X ICE Catheter, Sensor Enabled™
K251231 · OBJ
Abbott Medical
Cardiovascular · 28d