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
2857–2880 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 09, 2017
Wingman 14C Crossing Catheter
K170996 · DQY
Reflow Medical, Inc.
Cardiovascular · 67d
Cleared Jun 09, 2017
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Jun 08, 2017
Sorin Connect
K170460 · DXJ
Sorin Group Deutschland GmbH
Cardiovascular · 113d
Cleared Jun 07, 2017
Venture 038 catheter
K171335 · DQY
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Jun 07, 2017
Digital Automatic Blood Pressure Monitor MD3600
K163679 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 162d
Cleared Jun 07, 2017
Advanced Perfusion System 1
K163531 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 173d
Cleared Jun 06, 2017
EK12 Algorithm
K170155 · MHX
Ge Medical Systems Information...
Cardiovascular · 139d
Cleared Jun 05, 2017
LiDCOunity v2 Hemodynamic Monitor
K163334 · DXG
Lidco, Ltd.
Cardiovascular · 189d
Cleared Jun 02, 2017
Tubing Pack
K171308 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 02, 2017
Electrocardiograph
K170995 · DPS
Edan Instruments, Inc.
Cardiovascular · 60d
Cleared Jun 02, 2017
VitalWatch Software User Interface
K170973 · DRG
Vitalconnect, Inc.
Cardiovascular · 60d
Cleared Jun 02, 2017
Biopsy Forceps
K170726 · DWZ
Fehling Instruments GmbH & Co. KG
Cardiovascular · 85d
Cleared Jun 02, 2017
Reprocessed Agilis NxT Steerable Introducer
K170311 · PNE
Innovative Health, LLC
Cardiovascular · 121d
Cleared Jun 02, 2017
Zio AT ECG Monitoring System
K163512 · QYX
iRhythm Technologies, Inc.
Cardiovascular · 169d
Cleared Jun 01, 2017
Medcomp Vessel Dilator
K162389 · DRE
Medcomp ( Medical Components)
Cardiovascular · 279d
Not Cleared Jun 01, 2017
Sentinel Cerebral Protection System
DEN160043 · PUM
Claret Medical, Inc.
Cardiovascular · 254d
Cleared May 31, 2017
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
K171268 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 30d
Cleared May 31, 2017
Lympha Press Optimal Plus
K170658 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 89d
Cleared May 30, 2017
Portable ECG Monitor
K170954 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 60d
Cleared May 30, 2017
VenaCure EVLT NeverTouch Direct Introducer Sheath
K170695 · DYB
AngioDynamics, Inc.
Cardiovascular · 84d
Cleared May 30, 2017
Pulse* Spray Infusion System, Uni*Fuse Infusion System
K163356 · QEY
AngioDynamics, Inc.
Cardiovascular · 181d
Cleared May 26, 2017
Mistral-Air Warming Unit
K171234 · DWJ
The Surgical Company International BV...
Cardiovascular · 29d
Cleared May 26, 2017
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
K171217 · DXT
Osprey Medical, Inc.
Cardiovascular · 30d
Cleared May 26, 2017
Flexitouch System
K170216 · JOW
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 122d