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
649–672 of 18,110
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 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