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
2737–2760 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 18, 2017
ECG SENTINEL System
K172801 · DXH
Cardiomedix, Inc.
Cardiovascular · 30d
Cleared Oct 18, 2017
NovaCross Microcatheter
K172297 · DQY
Nitiloop , Ltd.
Cardiovascular · 79d
Cleared Oct 18, 2017
Liberator Beacon Tip Locking Stylet
K170298 · DRB
Cook Incorporated
Cardiovascular · 260d
Cleared Oct 17, 2017
EnsoETM
K172493 · PLA
Attune Medical
Cardiovascular · 60d
Cleared Oct 17, 2017
RVS-100 Vital Signs Monitor
K170538 · MWI
Rudolf Riester GmbH
Cardiovascular · 236d
Cleared Oct 16, 2017
Coaxial Dilator Set (Micro-Introducer)
K172487 · DRE
Galt Medical Corp.
Cardiovascular · 60d
Cleared Oct 16, 2017
AcQMap High Resolution Imaging and Mapping System
K170948 · DQK
Acutus Medical, Inc.
Cardiovascular · 200d
Cleared Oct 16, 2017
AcQMap 3D Imaging and Mapping Catheter
K170819 · MTD
Acutus Medical, Inc.
Cardiovascular · 210d
Cleared Oct 13, 2017
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
K172498 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 56d
Cleared Oct 13, 2017
Electronic Blood Pressure Monitor
K170151 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 269d
Cleared Oct 12, 2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
K172305 · DSP
Datascope Corp.
Cardiovascular · 73d
Cleared Oct 12, 2017
Creavo Vitalscan Magnetocardiograph
K170154 · DPS
Creavo Medical Technologies, Ltd.
Cardiovascular · 267d
Cleared Oct 10, 2017
higi Station (with Body Composition and Pan and Tilt cuff housing), higi...
K172739 · DXN
Higi Sh, LLC
Cardiovascular · 28d
Cleared Oct 10, 2017
3M Bair Hugger Model 675 Total Temperature Management System
K171373 · DWJ
3M Company
Cardiovascular · 153d
Cleared Oct 06, 2017
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3
K171801 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 112d
Cleared Oct 05, 2017
Shoocin Introducer Kit
K172099 · DYB
Lepu Medical Technology (Beijing)...
Cardiovascular · 86d
Cleared Oct 05, 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · NLH
Innovative Health, LLC
Cardiovascular · 135d
Cleared Oct 05, 2017
R2P Destination Slender Guiding Sheath
K171491 · DYB
Terumo Medical Corporation
Cardiovascular · 136d
Cleared Oct 02, 2017
ECG Check - Universal, ECG Check - Universal Plus
K170506 · DXH
Cardiac Designs, Inc.
Cardiovascular · 223d
Cleared Sep 29, 2017
Confirm Rx Insertable Cardiac Monitor (ICM) System
K163407 · MXC
St. Jude Medical, Inc.
Cardiovascular · 298d
Cleared Sep 28, 2017
Peel-Away Introducer Set
K170020 · DYB
Cook Incorporated
Cardiovascular · 268d
Cleared Sep 27, 2017
Peerbridge Cor(TM) System
K171936 · DSH
Peerbridge Health, Inc.
Cardiovascular · 91d
Cleared Sep 25, 2017
Electrocardiograph
K171943 · DPS
Edan Instruments, Inc.
Cardiovascular · 89d
Cleared Sep 22, 2017
ULTRASCORE Focused Force PTA Balloon
K172571 · PNO
C. R. Bard
Cardiovascular · 25d