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
481–504 of 18,182
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 CT 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 CT 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