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
7825–7848 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 06, 2003
KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K030359 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 276d
Cleared Nov 06, 2003
VITERION 100 TELEHEALTH MONITOR
K030419 · MWI
Viterion Telehealthcare, LLC
Cardiovascular · 269d
Cleared Nov 06, 2003
LIFEPAK 12, 20, 500, CR PLUS
K033275 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 27d
Cleared Nov 06, 2003
APEXPRO FH TELEMETRY SYSTEM
K033365 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Nov 05, 2003
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K032439 · MKJ
Zoll Medical Corp
Cardiovascular · 90d
Cleared Nov 05, 2003
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K033247 · DXT
Medrad, Inc.
Cardiovascular · 29d
Cleared Nov 05, 2003
SELECTIVA SB GUIDEWIRE
K033321 · DQX
Neometrics, Inc.
Cardiovascular · 21d
Cleared Nov 05, 2003
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP...
K033416 · DWF
Medtronic Perfusion Systems
Cardiovascular · 9d
Cleared Nov 03, 2003
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946 · DTM
Edwards Lifesciences, LLC
Cardiovascular · 132d
Cleared Oct 31, 2003
KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K030358 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 270d
Cleared Oct 31, 2003
JABES ELECTRONIC STETHOSCOPE
K031446 · DQD
Gs Technology Co., Ltd.
Cardiovascular · 177d
Cleared Oct 31, 2003
AUDICOR UPGRADE SYSTEM
K032145 · DPS
Inovise Medical, Inc.
Cardiovascular · 109d
Cleared Oct 31, 2003
ZOLL M SERIES NIBP OPTION
K032363 · DXN
Zoll Medical Corp
Cardiovascular · 92d
Cleared Oct 31, 2003
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · DTK
Cook, Inc.
Cardiovascular · 86d
Cleared Oct 31, 2003
MODIFICATION TO GLOBALCARDIO
K033037 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 32d
Cleared Oct 31, 2003
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
K033130 · DTE
Osypka Medical, Inc.
Cardiovascular · 31d
Cleared Oct 31, 2003
PHERON PTA CATHETER
K033217 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Oct 31, 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL...
K033264 · DWF
Medtronic Perfusion Systems
Cardiovascular · 22d
Cleared Oct 31, 2003
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K033305 · DSI
Draeger Medical Systems, Inc.
Cardiovascular · 17d
Cleared Oct 30, 2003
ENDOHELIX ENDARTERECTOMY DEVICE
K032105 · DWX
Endarx, Inc.
Cardiovascular · 114d
Cleared Oct 30, 2003
A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS
K032499 · DXN
A&D Engineering, Inc.
Cardiovascular · 78d
Cleared Oct 30, 2003
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · DQK
Ge Medical Systems Information...
Cardiovascular · 77d
Cleared Oct 30, 2003
ENSITE SYSTEM
K033211 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 27d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 86d