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
1897–1920 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 03, 2020
Halo™ Single-Loop Snare Kit
K200268 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 121d
Cleared Jun 01, 2020
ProCell Surgical Sponge-Blood Recovery Unit
K193361 · CAC
Procell Surgical, Inc.
Cardiovascular · 180d
Cleared Jun 01, 2020
UNI*FUSE Infusion System with Cooper Wire
K192864 · QEY
AngioDynamics, Inc.
Cardiovascular · 238d
Cleared Jun 01, 2020
Vitls Platform
K191620 · DRG
Vitls, Inc.
Cardiovascular · 349d
Cleared May 29, 2020
iLab Polaris Multi-Modality Guidance System
K201178 · DQK
Boston Scientific
Cardiovascular · 28d
Cleared May 29, 2020
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
K193495 · PNO
Transit Scientific
Cardiovascular · 164d
Cleared May 29, 2020
Automatic Digital Blood Pressure Monitor
K190982 · DXN
Xiamen Ants Bro Technology Co., Ltd.
Cardiovascular · 410d
Cleared May 28, 2020
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
K192981 · QEW
Penumbra, Inc.
Cardiovascular · 217d
Cleared May 27, 2020
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112 · DSP
Arrow International, Inc.
Cardiovascular · 30d
Cleared May 22, 2020
Reconnaissance PV .018 OTW Digital IVUS Catheter
K200410 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 93d
Cleared May 21, 2020
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K201068 · KFM
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 21, 2020
BeneVision Central Monitoring System
K193391 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 167d
Cleared May 20, 2020
Infinity Angioplasty Balloon Catheter
K192399 · LIT
Infinity Angioplasty Balloon Company,...
Cardiovascular · 260d
Cleared May 15, 2020
BP-BT Kiosk
K200287 · DXN
Ld Technology, LLC
Cardiovascular · 100d
Cleared May 15, 2020
Medtronic Commander Flex
K191745 · DXN
Medtronic Care Management Services
Cardiovascular · 319d
Cleared May 14, 2020
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal...
K200700 · LIT
Creagh Medical, Ltd.
Cardiovascular · 58d
Cleared May 14, 2020
Support Catheter
K200317 · DQY
Qxmedical, LLC
Cardiovascular · 97d
Cleared May 13, 2020
Medtronic Model 5392 External Pulse Generator (EPG)
K201011 · DTE
Medtronic, Inc.
Cardiovascular · 26d
Cleared May 13, 2020
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
K200205 · NLH
Stryker Sustainability Solutions
Cardiovascular · 106d
Cleared May 12, 2020
Disposable ECG Cable
K200026 · DSA
Shenzhen Changke Connect Electronics...
Cardiovascular · 127d
Cleared May 11, 2020
Critical Alert CommonPath Enterprise
K193043 · MSX
Critical Alert
Cardiovascular · 193d
Cleared May 07, 2020
LiteSaber Wire Torque Assist Device
K200120 · DQX
Vesatek, LLC
Cardiovascular · 107d
Cleared May 07, 2020
Patient Monitor
K192972 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 196d
Cleared May 06, 2020
XO Cross Support Catheter
K193420 · DQY
Transit Scientific
Cardiovascular · 149d