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
4057–4080 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 11, 2014
GUAVA II
K122632 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 531d
Cleared Feb 10, 2014
ARTASSIST AND VENASSIST
K131146 · JOW
Aci Medical, LLC
Cardiovascular · 293d
Cleared Feb 07, 2014
MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER...
K133552 · DRA
Hansen Medical
Cardiovascular · 80d
Cleared Feb 07, 2014
ALERTWATCH: OR
K130401 · MHX
Alertwatch, LLC
Cardiovascular · 353d
Cleared Feb 06, 2014
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH
K140036 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 30d
Cleared Feb 06, 2014
NUVANT MCT SYSTEM
K133701 · QYX
Corventis, Inc.
Cardiovascular · 65d
Cleared Feb 06, 2014
VDRIVE WITH V-SONO
K133396 · DQX
Stereotaxis, Inc.
Cardiovascular · 92d
Cleared Feb 06, 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133394 · MWI
Airstrip Technologies, LP
Cardiovascular · 93d
Cleared Feb 06, 2014
ALIVECOR HEART MONITOR OTC
K130921 · DPS
AliveCor, Inc.
Cardiovascular · 309d
Cleared Feb 05, 2014
CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
K140015 · DYB
Cardiosolutions, Inc.
Cardiovascular · 34d
Cleared Feb 03, 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
K133151 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 109d
Cleared Feb 03, 2014
SHOOCIN INTRODUCER KIT
K123475 · DYB
Lepu Medical Technology (Beijing)...
Cardiovascular · 447d
Cleared Jan 31, 2014
SORIN FLEXTHERM
K140012 · DWC
Sorin Group Deutschland GmbH
Cardiovascular · 29d
Cleared Jan 31, 2014
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
K132807 · MWI
Welch Allyn, Inc.
Cardiovascular · 144d
Cleared Jan 31, 2014
ENLIGHTN RENAL GUIDE CATHETER
K131592 · DQY
St. Jude Medical, Inc.
Cardiovascular · 242d
Cleared Jan 30, 2014
CRUX SNARE FILTER RETRIEVAL SET
K133681 · MMX
Volcano Corporation
Cardiovascular · 59d
Cleared Jan 30, 2014
DIGITAL ELECTROCARDIOGRAPH
K132758 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 148d
Cleared Jan 30, 2014
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
K132474 · DXO
Acist Medical Systems
Cardiovascular · 176d
Cleared Jan 30, 2014
CARDIOCEL
K130872 · DXZ
Celxcel Pty, Ltd.
Cardiovascular · 307d
Cleared Jan 29, 2014
TANDEMHEART FEMORAL VENOUS CANNULA SET
K133236 · DWF
Cardiacassist, Inc.
Cardiovascular · 100d
Cleared Jan 29, 2014
MOORLDLS-BI LASER DOPPLER BURNS IMAGER
K132163 · DPT
Moor Instruments, Ltd.
Cardiovascular · 201d
Cleared Jan 29, 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · DQY
Cook, Inc.
Cardiovascular · 275d
Cleared Jan 24, 2014
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
K132782 · DQK
Biosense Webster, Inc.
Cardiovascular · 140d
Cleared Jan 23, 2014
MAC 2000 ECG ANALYSIS SYSTEM
K133622 · DPS
Wipro GE Healthcare
Cardiovascular · 62d