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
2833–2856 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 30, 2017
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall...
K171621 · MHX
Welch Allyn, Inc.
Cardiovascular · 28d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 30, 2017
Gelweave Vascular Grafts
K162794 · DSY
Vascutek, Ltd.
Cardiovascular · 269d
Cleared Jun 29, 2017
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
K171514 · MXD
Biotronik, Inc.
Cardiovascular · 36d
Cleared Jun 29, 2017
Firebow Wire Torque Assist Device
K170684 · DQX
Vesatek, LLC
Cardiovascular · 114d
Cleared Jun 29, 2017
Vessel Dilator
K163524 · DWP
Fetzer Medical GmbH & Co. KG
Cardiovascular · 196d
Cleared Jun 26, 2017
CardioLogs ECG Analysis Platform
K170568 · DPS
Cardiologs Technologies
Cardiovascular · 119d
Cleared Jun 23, 2017
Ossler Exam Scope
K171188 · DRG
Lr Med, Inc.
Cardiovascular · 60d
Cleared Jun 23, 2017
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger...
K171146 · DQY
Arrow International, Inc. (Subsidiary...
Cardiovascular · 65d
Cleared Jun 22, 2017
Merit Hydrophilic Guide Wire
K170933 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 85d
Cleared Jun 22, 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K170922 · NLH
Innovative Health, LLC
Cardiovascular · 85d
Cleared Jun 22, 2017
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
K163316 · DSA
Carefusion 303, Inc.
Cardiovascular · 211d
Cleared Jun 22, 2017
CoVa Monitoring System 2
K160899 · MWI
Tosense, Inc.
Cardiovascular · 447d
Cleared Jun 21, 2017
TVC Imaging System, TVC Catheter
K163345 · OGZ
Infraredx, Inc.
Cardiovascular · 204d
Cleared Jun 16, 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Jun 16, 2017
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque...
K170191 · MCW
Medtronic Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 16, 2017
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
K162215 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 312d
Cleared Jun 15, 2017
AcuNav V 10F Ultrasound Catheter
K170992 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 73d
Cleared Jun 15, 2017
AcuNav Diagnostic Ultrasound Catheter 8F,10F
K170263 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 139d
Cleared Jun 15, 2017
Merit Coronary Control Syringe
K163084 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 224d
Cleared Jun 14, 2017
TONOPORT VI
K170966 · DXN
Par Medizintechnik GmbH & Co. KG
Cardiovascular · 75d
Cleared Jun 14, 2017
UltraScore Focused Force PTA Balloon
K163420 · PNO
Bard Peripheral Vascular, Inc.
Cardiovascular · 190d
Cleared Jun 13, 2017
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
K171427 · OTD
Medtronic Vascular, Inc.
Cardiovascular · 29d
Cleared Jun 12, 2017
SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon...
K162625 · LOX
B. Braun Interventional Systems, Inc.
Cardiovascular · 265d