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
5185–5208 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 22, 2011
MIDMARK IQECG
K103640 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 99d
Cleared Mar 22, 2011
LIFEPAK 15 MONITOR/DEFIBRILLATOR
K103567 · MKJ
Physio-Control, Inc.
Cardiovascular · 106d
Cleared Mar 22, 2011
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K101422 · DYB
Access Scientific, Inc.
Cardiovascular · 306d
Cleared Mar 21, 2011
HEM-4030
K110501 · DXN
Omron Healthcare, Inc.
Cardiovascular · 27d
Cleared Mar 21, 2011
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES
K110299 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 48d
Cleared Mar 21, 2011
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
K100424 · MWI
Danmedical Limited
Cardiovascular · 398d
Cleared Mar 18, 2011
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
K110553 · DQX
Asahi Intecc USA, Inc.
Cardiovascular · 18d
Cleared Mar 18, 2011
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
K102588 · DRF
Medtronic Ablation Frontiers, LLC
Cardiovascular · 190d
Cleared Mar 15, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110018 · DXN
Andon Health Co, Ltd.
Cardiovascular · 71d
Cleared Mar 15, 2011
STAR 50 N
K103686 · MWI
Larsen & Toubro Limited
Cardiovascular · 88d
Cleared Mar 11, 2011
STEALTH 360 ORBITAL PAD SYSTEM
K110389 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 29d
Cleared Mar 11, 2011
STELLAR 300
K103763 · MWI
Larsen & Toubro Limited
Cardiovascular · 78d
Cleared Mar 11, 2011
FUKUDA DENSHI
K103134 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 137d
Cleared Mar 11, 2011
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL...
K102919 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 161d
Cleared Mar 11, 2011
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 375d
Cleared Mar 10, 2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM)
K110503 · MWI
Airstrip Technologies, LP
Cardiovascular · 16d
Cleared Mar 08, 2011
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
K110361 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 29d
Cleared Mar 08, 2011
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL...
K103191 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 131d
Cleared Mar 07, 2011
ASAHI GUIDE WIRE EXTENSION 165CM
K101985 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 236d
Cleared Mar 04, 2011
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL...
K102464 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 189d
Cleared Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295 · KRD
Boston Scientific Corp
Cardiovascular · 30d
Cleared Mar 03, 2011
SPACELABS MULTI-PARAMETER MODULE
K103142 · DSI
Spacelabs Healthcare, Inc.
Cardiovascular · 129d
Cleared Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
K102912 · KRD
Boston Scientific
Cardiovascular · 153d
Cleared Mar 03, 2011
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · DXT
Medline Industries, Inc.
Cardiovascular · 444d