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
2305–2328 of 18,110
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