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
721–744 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 01, 2024
Infinity CentralStation Wide
K240312 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 181d
Cleared Jul 31, 2024
ValvuloPro Valvuloplasty Balloon Catheter
K240967 · OZT
Dongguan TT Medical, Inc.
Cardiovascular · 113d
Cleared CT Jul 31, 2024
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava...
K240578 · DTK
B.Braun Medical, Inc.
Cardiovascular · 152d
Cleared Jul 29, 2024
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · PZX
AtriCure, Inc.
Cardiovascular · 214d
Cleared Jul 26, 2024
STAR Apollo™ Mapping System
K240509 · DQK
Rhythm AI, Ltd.
Cardiovascular · 155d
Cleared Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · DRC
Synaptic Medical Corporation
Cardiovascular · 178d
Cleared Jul 24, 2024
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)
K241243 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 82d
Cleared Jul 23, 2024
AITRICS-VC
K240756 · PLB
Aitrics Co., Ltd.
Cardiovascular · 125d
Cleared Jul 22, 2024
NAVOYCDS
K240558 · PLB
Algodx AB
Cardiovascular · 145d
Cleared Jul 19, 2024
VasoGuard (V10, V8, V6, V4, V2)
K233976 · JOP
Corvascular Diagnostics, LLC
Cardiovascular · 217d
Cleared Jul 18, 2024
Quantum Perfusion Hybrid System
K241206 · DTN
Spectrum Medical S.R.L.
Cardiovascular · 79d
Cleared Jul 18, 2024
ICHOR 7F Embolectomy System (ICH-7F)
K233917 · QEW
Ichor
Cardiovascular · 219d
Cleared Jul 17, 2024
ACIST RXi System (016616)
K233904 · DXO
Acist Medical Systems, Inc.
Cardiovascular · 219d
Cleared Jul 16, 2024
Finesse Injectable™ PTA Balloon Dilatation Catheter
K241740 · LIT
Summa Therapeutics
Cardiovascular · 29d
Cleared Jul 12, 2024
VersaCross Connect™ Transseptal Dilator
K241720 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 28d
Cleared Jul 12, 2024
Infinity Gateway Suite
K233834 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 221d
Cleared Jul 11, 2024
Oscar Peripheral Multifunctional Catheter system
K241711 · LIT
Biotronik, Inc.
Cardiovascular · 27d
Cleared Jul 10, 2024
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )
K241683 · LIT
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 10, 2024
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
K240666 · DTZ
Medtronic Perfusion Systems
Cardiovascular · 124d
Cleared Jul 09, 2024
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · MTD
Abbott Medical
Cardiovascular · 55d
Cleared Jul 08, 2024
RhythmStar System
K233584 · QYX
RhythMedix, LLC
Cardiovascular · 244d
Cleared Jul 03, 2024
Upper Arm Electronic Blood Pressure Monitor
K241129 · DXN
Shenzhen Goodlymed Technology Co., Ltd.
Cardiovascular · 70d
Cleared Jul 02, 2024
Fogarty Fortis Arterial Embolectomy Catheter
K241330 · DXE
Edwards Lifesciences
Cardiovascular · 53d
Cleared Jul 01, 2024
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
K231015 · NLI
Innovative Health, LLC
Cardiovascular · 448d