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
2953–2976 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 07, 2017
RenovoCath
K160067 · MJN
Renovorx, Inc.
Cardiovascular · 419d
Cleared Mar 03, 2017
Inqwire Diagnostic Guide Wire
K163575 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 74d
Cleared Mar 03, 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524 · KRD
MicroVention, Inc.
Cardiovascular · 175d
Cleared Feb 28, 2017
FIRMap Catheter
K163709 · MTD
Abbott Electrophysiology
Cardiovascular · 60d
Cleared Feb 28, 2017
CareLink SmartSync Device Manager - Pacing System Analyzer
K163008 · DTA
Medtronic, Inc.
Cardiovascular · 123d
Cleared Feb 27, 2017
Flextra Steerable Introducer
K170373 · DYB
Rhythm Xience, Inc. (Rxi)
Cardiovascular · 20d
Cleared Feb 24, 2017
EkoSonic Endovascular System with Control Unit 4.0
K162771 · QEY
Btg International, Inc.
Cardiovascular · 144d
Cleared Feb 23, 2017
Reveal LINQ
K162855 · MXD
Medtronic, Inc.
Cardiovascular · 134d
Cleared Feb 22, 2017
my Patch sl
K163535 · DSH
Dms-Service, LLC
Cardiovascular · 68d
Cleared Feb 21, 2017
SpeedLyser Infusion Catheter Kit
K170258 · QEY
AngioDynamics, Inc.
Cardiovascular · 25d
Cleared Feb 21, 2017
ClearLumen II Peripheral Thrombectomy System
K163051 · QEZ
Walk Vascular, LLC
Cardiovascular · 112d
Cleared Feb 21, 2017
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
K163045 · DXN
Omron Healthcare, Inc.
Cardiovascular · 113d
Cleared Feb 18, 2017
VIA 17 Microcatheter
K162565 · DQY
Sequent Medical, Inc.
Cardiovascular · 157d
Cleared Feb 17, 2017
Sentry IVC filter
K162875 · DTK
Novate Medical , Ltd.
Cardiovascular · 126d
Cleared Feb 16, 2017
ClotTriever Thrombectomy System
K163549 · QEW
Inari Medical, Inc.
Cardiovascular · 62d
Cleared Feb 16, 2017
RF1400 Active Compression Wrap
K162481 · JOW
Recovery Force, LLC
Cardiovascular · 163d
Cleared Feb 15, 2017
PC ECG
K160876 · DPS
Edan Instruments, Inc.
Cardiovascular · 322d
Cleared Feb 14, 2017
Reveal LINQ Insertable Cardiac Monitor
K163460 · MXD
Medtronic, Inc.
Cardiovascular · 67d
Cleared Feb 14, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162668 · DXN
Andon Health Co, Ltd.
Cardiovascular · 141d
Cleared Feb 13, 2017
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
K170193 · LIT
Cook Incorporated
Cardiovascular · 21d
Cleared Feb 13, 2017
Serranator Alto PTA Serration Balloon Catheter
K163380 · PNO
Cagent Vascular, LLC
Cardiovascular · 74d
Cleared Feb 10, 2017
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K162774 · DTR
Medtronic, Inc.
Cardiovascular · 130d
Cleared Feb 10, 2017
Blood Pressure Monitor
K162089 · DXN
Beijing Choice Electronic Technology...
Cardiovascular · 197d
Cleared Feb 09, 2017
AcuNav Volume ICE Catheter
K163478 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 59d