Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
1969–1992 of 18,182
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