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
2377–2400 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 12, 2019
FORA P100 Blood Pressure Monitoring System
K182934 · DXN
Taidoc Technology Corporation
Cardiovascular · 113d
Cleared Feb 11, 2019
IntraSight
K190078 · DSA
Volcano Corporation
Cardiovascular · 26d
Cleared Feb 08, 2019
Coala Heart Monitor
K182040 · DXH
Coala Life AB
Cardiovascular · 193d
Cleared Feb 07, 2019
AcQMap High Resolution Imaging and Mapping System
K181577 · DQK
Acutus Medical, Inc.
Cardiovascular · 237d
Cleared Feb 06, 2019
WavelinQ 4F EndoAVF System
K182796 · PQK
C.R. Bard, Inc.
Cardiovascular · 128d
Cleared Jan 30, 2019
Patient Cables and Leadwires , Disposable ECG Leadwires
K182327 · DSA
Orantech, Inc.
Cardiovascular · 156d
Cleared Jan 28, 2019
ZOLL ECG Analysis Software
K182093 · DPS
Zoll Manufacturing Corporation
Cardiovascular · 178d
Cleared Jan 25, 2019
medi pneumatic compression system (pcs) – brio (Model 651)
K183631 · JOW
Medi USA, LP
Cardiovascular · 30d
Cleared Jan 25, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys...
K183615 · PQK
Avenu Medical, Inc.
Cardiovascular · 30d
Cleared Jan 24, 2019
Surveyor S2
K182297 · DRG
Mortara Instrument, Inc.
Cardiovascular · 153d
Cleared Jan 24, 2019
Reprocessed CS Diagnostic Electrophysiology Catheter
K181056 · NLH
Stryker Sustainability Solutions
Cardiovascular · 279d
Cleared Jan 21, 2019
XableCath Crossing Catheter
K183357 · PDU
Xablecath, Inc.
Cardiovascular · 48d
Cleared Jan 18, 2019
Reprocessed Visions PV .035 Digital IVUS Catheter
K181126 · OWQ
Innovative Health, LLC
Cardiovascular · 263d
Cleared Jan 17, 2019
Study Watch
K182456 · DXH
Verily Life Sciences, LLC
Cardiovascular · 132d
Cleared Jan 16, 2019
Merit RadialFlo Arterial Catheter
K182538 · FOZ
Merit Medical Singapore Pte. , Ltd.
Cardiovascular · 124d
Cleared Jan 11, 2019
Roadrunner Extra Support Wire Guide
K183467 · DQX
Cook Incorporated
Cardiovascular · 28d
Cleared Jan 03, 2019
Arm Blood Pressure Monitor
K180435 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 317d
Cleared Dec 29, 2018
ViperCath XC Peripheral Exchange Catheter
K183000 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 60d
Cleared Dec 28, 2018
COR12 ECG
K183369 · DPS
Corscience GmbH & Co.
Cardiovascular · 24d
Cleared Dec 21, 2018
Pulse Rx 2.0, Pulse Pro Rx 2.0
K183328 · JOW
NormaTec Industries, LP
Cardiovascular · 21d
Cleared Dec 21, 2018
The ICHOR Panacea Vascular Embolectomy Catheter System
K182167 · QEW
Ichor Vascular, Inc.
Cardiovascular · 133d
Cleared Dec 21, 2018
vital signs monitor
K180380 · DQA
Edan Instruments, Inc.
Cardiovascular · 312d
Cleared Dec 21, 2018
North-vision Multi-parameter Patient Monitor
K173036 · MHX
North-Vision Tech., Inc.
Cardiovascular · 449d
Cleared Dec 20, 2018
DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction...
K183267 · DXT
Osprey Medical, Inc.
Cardiovascular · 27d