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
6625–6648 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 11, 2007
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
K071073 · MHX
Ge Medical Systems Information...
Cardiovascular · 25d
Cleared May 11, 2007
FETCH ASPIRATION CATHETER
K070363 · QEZ
Possis Medical, Inc.
Cardiovascular · 93d
Cleared May 11, 2007
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
K063638 · DQY
St Jude Medical
Cardiovascular · 155d
Cleared May 10, 2007
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
K070086 · DXN
Sensacare , Ltd.
Cardiovascular · 121d
Cleared May 09, 2007
COLIN PRESS MATE, MODEL BP S510
K063690 · MHX
Omron Healthcare, Inc.
Cardiovascular · 148d
Cleared May 04, 2007
CORSCREEN
K070614 · DPS
Viasys Healthcare GmbH
Cardiovascular · 60d
Cleared May 04, 2007
CARTO XP EP NAVIGATION SYSTEM, VERSION 9
K070240 · DQK
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared May 03, 2007
IPC-BOOT
K070324 · JOW
C-Boot , Ltd.
Cardiovascular · 87d
Cleared May 02, 2007
247 BP DEVICE
K070750 · DXN
Suntech Medical, Inc.
Cardiovascular · 44d
Cleared May 02, 2007
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL...
K052480 · DXX
Hansen Medical, Inc.
Cardiovascular · 600d
Cleared May 01, 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · DQK
St Jude Medical
Cardiovascular · 29d
Cleared May 01, 2007
PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
K063137 · DXN
Pharmasmart, Inc.
Cardiovascular · 197d
Cleared Apr 27, 2007
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
K071011 · MWJ
Braemar, Inc.
Cardiovascular · 17d
Cleared Apr 27, 2007
COOK MICROWIRE WIRE GUIDE
K070410 · DQX
Cook, Inc.
Cardiovascular · 74d
Cleared Apr 27, 2007
RUNTHROUGH NS
K063695 · DQX
Terumo Medical Corp.
Cardiovascular · 135d
Cleared Apr 27, 2007
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
K063503 · IZQ
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 158d
Cleared Apr 26, 2007
ZOLL E SERIES WITH SEE-THRU CPR
K070455 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 69d
Cleared Apr 24, 2007
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
K070839 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Apr 20, 2007
COOK CELECT VENA CAVA FILTER
K061815 · DTK
William Cook Europe Aps
Cardiovascular · 297d
Cleared Apr 19, 2007
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
K070710 · DRS
Biosensors International-USA
Cardiovascular · 36d
Cleared Apr 19, 2007
HORIZON SE
K070254 · DQK
Mennen Medical , Ltd.
Cardiovascular · 83d
Cleared Apr 16, 2007
DYE MANAGEMENT SYSTEM
K063784 · DQO
Icu Medical, Inc.
Cardiovascular · 116d
Cleared Apr 13, 2007
AUDICOR 200 SYSTEM, MODELS 200D AND 200S
K070136 · DPS
Inovise Medical, Inc.
Cardiovascular · 87d
Cleared Apr 13, 2007
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · IZQ
E-Z-Em, Inc.
Cardiovascular · 234d