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
8881–8904 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 07, 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085 · DQY
Concentric Medical, Inc.
Cardiovascular · 155d
Cleared Mar 07, 2001
FLEXVIEW CLINICAL MONITORING SYSTEM
K003998 · MSX
Data Critical Corp.
Cardiovascular · 71d
Cleared Mar 07, 2001
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
K010338 · DWJ
Medivance, Inc.
Cardiovascular · 30d
Cleared Mar 02, 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
K010330 · DSP
Arrow Intl., Inc.
Cardiovascular · 28d
Cleared Mar 02, 2001
M2376A DEVICELINK SYSTEM
K010453 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · DQK
Boston Scientific Corp
Cardiovascular · 125d
Cleared Mar 01, 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 8d
Cleared Feb 28, 2001
VASCULAR ARCHITECTS PERISCOPE DEVICE
K003719 · DWX
Vascular Architects, Inc.
Cardiovascular · 86d
Cleared Feb 28, 2001
ZOLL M SERIES
K010257 · MKJ
Zoll Medical Corp
Cardiovascular · 30d
Cleared Feb 28, 2001
CARDIOMEDICS ECP SYSTEM
K010261 · DRN
Cardiomedics, Inc.
Cardiovascular · 30d
Cleared Feb 22, 2001
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K002079 · MKJ
Medicotest A/S
Cardiovascular · 227d
Cleared Feb 22, 2001
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT...
K002758 · DSI
Agilent Technologies Deutschland GmbH
Cardiovascular · 170d
Cleared Feb 22, 2001
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
K010214 · MKJ
Survivalink Corp.
Cardiovascular · 30d
Cleared Feb 21, 2001
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
K001852 · DQK
Itamar Medical (C.M.) 1997 , Ltd.
Cardiovascular · 247d
Cleared Feb 16, 2001
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90,...
K002054 · DYB
Appriva Medical, Inc.
Cardiovascular · 225d
Cleared Feb 14, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER
K003667 · MXC
Medtronic Vascular
Cardiovascular · 78d
Cleared Feb 14, 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · MTD
Boston Scientific Corp
Cardiovascular · 69d
Cleared Feb 14, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K010342 · MWI
Agilent Technologies, Inc.
Cardiovascular · 9d
Cleared Feb 13, 2001
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 42d
Cleared Feb 13, 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · DQY
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Feb 08, 2001
ORG-9200A
K002068 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 216d
Cleared Feb 08, 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · DRB
Medtronic Vascular
Cardiovascular · 84d
Cleared Feb 08, 2001
2010 PLUS HOLTER FOR WINDOWS
K003940 · MLO
Agilent Technologies
Cardiovascular · 49d
Cleared Feb 08, 2001
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
K010190 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 17d