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
4921–4944 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 05, 2011
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM...
K113213 · DRF
Biosense Webster, Inc.
Cardiovascular · 34d
Cleared Dec 05, 2011
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K112845 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 67d
Cleared Dec 02, 2011
ANGIOJET ULTRA DVX THROMBECTOMY SET
K113428 · QEZ
Medrad, Inc.
Cardiovascular · 11d
Cleared Dec 02, 2011
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · DXS
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 02, 2011
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K112559 · DRG
Medapps, Inc.
Cardiovascular · 91d
Cleared Dec 02, 2011
VOCARE MYHEALTH TABLET
K111922 · DRG
Vocare, Inc.
Cardiovascular · 149d
Cleared Dec 01, 2011
GUIDELINER V2 CATHETER
K112082 · DQY
Vascular Solutions, Inc.
Cardiovascular · 133d
Cleared Nov 30, 2011
CHARGER PTA BALLON DILATATION CATHETER
K112697 · LIT
Boston Scientific
Cardiovascular · 75d
Cleared Nov 28, 2011
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
K113198 · DXT
Navilyst Medical, Inc.
Cardiovascular · 28d
Cleared Nov 23, 2011
HOTDOG PATIENT WARMING SYSTEM
K112488 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 86d
Cleared Nov 23, 2011
RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A
K111748 · JOW
Joy Long
Cardiovascular · 154d
Cleared Nov 23, 2011
VITALOGRAPH MODEL 7100 - VITALOJAK
K110525 · DSH
Vitalograph (Ireland) , Ltd.
Cardiovascular · 273d
Cleared Nov 22, 2011
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
K112687 · MWI
Welch Allyn, Inc.
Cardiovascular · 68d
Cleared Nov 22, 2011
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
K112647 · DXN
Wistron Corporation
Cardiovascular · 71d
Cleared Nov 22, 2011
UNIMED BLOOD PRESSURE CUFF
K112544 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 82d
Cleared Nov 22, 2011
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
K112273 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Cleared Nov 22, 2011
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K112270 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Not Cleared Nov 21, 2011
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH...
DEN100026 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 342d
Cleared Nov 18, 2011
TRANSRADIAL ARTERY ACCESS DEVICES
K112554 · DYB
Teleflexmedical, Inc.
Cardiovascular · 77d
Cleared Nov 18, 2011
TAPAS CATHETER
K112219 · MJN
Thermopeutix, Inc.
Cardiovascular · 108d
Cleared Nov 18, 2011
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
K112050 · OBJ
Biosense Webster, Inc.
Cardiovascular · 123d
Cleared Nov 17, 2011
MOBCARDIO SYSTEM
K113234 · DPS
Mobhealth Incorporation
Cardiovascular · 15d
Cleared Nov 17, 2011
INTELLIVUE MX40 PATIENT MONITOR
K113125 · DSI
Philips Medical Systems
Cardiovascular · 24d
Cleared Nov 17, 2011
CLEARWAY RX NB CATHETER
K113112 · DQY
Atrium Medical Corp.
Cardiovascular · 28d