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
3865–3888 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 12, 2014
LLD EZ
K142116 · DRB
Spectranetics, Inc.
Cardiovascular · 8d
Cleared Aug 12, 2014
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
K134014 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 225d
Cleared Aug 07, 2014
HI-TORQUE VERSATURN GUIDE WIRE
K141782 · DQX
Abbott Vascular
Cardiovascular · 36d
Cleared Aug 07, 2014
MAGELLAN ROBOTIC SYSTEM
K141614 · DXX
Hansen Medical
Cardiovascular · 52d
Cleared Aug 07, 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION...
K141236 · LOX
Boston Scientific Corporation
Cardiovascular · 86d
Cleared Aug 07, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED)...
K141209 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 90d
Cleared Aug 06, 2014
TANDEMHEART VENO-VENOUS CANNULA
K140999 · DWF
Cardiacassist, Inc.
Cardiovascular · 110d
Cleared Aug 06, 2014
SAAD PATIENT MONITOR (SPM)
K133222 · MHX
Hanin Medical Services Co., Ltd.
Cardiovascular · 292d
Cleared Aug 05, 2014
SENSEI X ROBOTIC CATHETER SYSTEM
K141822 · DXX
Hanson Medical, Inc.
Cardiovascular · 29d
Cleared Aug 05, 2014
RHYTHMSTAR SYSTEM
K141813 · DXH
RhythMedix, LLC
Cardiovascular · 29d
Cleared Aug 04, 2014
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
K141496 · MUD
Reflectance Medical, Inc.
Cardiovascular · 59d
Cleared Aug 01, 2014
ZOLL X SERIES
K133484 · MKJ
Zoll Medical Corp
Cardiovascular · 261d
Cleared Aug 01, 2014
TEBCO-W
K132892 · DXG
Bomed, Inc.
Cardiovascular · 319d
Cleared Aug 01, 2014
PASSPORT SERIES PATIENT MONITORS
K132662 · MHX
Shenzhen Mindray Biomedical...
Cardiovascular · 340d
Cleared Jul 31, 2014
SYVEK RADIAL BAND
K132293 · DXC
Marine Polymer Technologies
Cardiovascular · 373d
Cleared Jul 29, 2014
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE...
K141167 · DRG
Vitalconnect, Inc.
Cardiovascular · 84d
Cleared Jul 28, 2014
MR SYRINGE DUAL PACK
K140469 · DXT
Coeur, Inc.
Cardiovascular · 153d
Cleared Jul 25, 2014
COCOON CONVECTIVE WARMING SYSTEM
K140635 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 135d
Cleared Jul 25, 2014
BELTER BLOOD PRESSURE METER
K134029 · DXN
Shenzhen Belter Health Measurement...
Cardiovascular · 206d
Cleared Jul 25, 2014
CDI BLOOD PARAMETER MONITORING SYSTEM 500
K133658 · DRY
Terumo Cardiovascular Systems Corp.
Cardiovascular · 240d
Cleared Jul 24, 2014
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
K140096 · DRX
Hmicro, Inc.
Cardiovascular · 191d
Cleared Jul 23, 2014
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
K140775 · MCW
Spectranetics Corporation
Cardiovascular · 117d
Cleared Jul 22, 2014
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · NTE
Abbott Vascular
Cardiovascular · 29d
Cleared Jul 22, 2014
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · MJN
Boston Scientific Corp
Cardiovascular · 169d