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
3961–3984 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 15, 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K140329 · KRA
Boston Scientific
Cardiovascular · 94d
Cleared May 08, 2014
ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
K140755 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 43d
Cleared May 02, 2014
ACCUTORR 7 VITAL SIGNS MONITOR
K132038 · MWI
Mindray North America
Cardiovascular · 305d
Cleared May 01, 2014
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
K140185 · PDU
Avinger, Inc.
Cardiovascular · 97d
Cleared Apr 30, 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · DXJ
Ge Medical Systems Information...
Cardiovascular · 131d
Cleared Apr 30, 2014
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
K133600 · DXT
Coeur, Inc.
Cardiovascular · 156d
Cleared Apr 30, 2014
MEDTRONIC INPUT PS INTRODUCER
K132617 · DYB
Medtronic, Inc.
Cardiovascular · 252d
Cleared Apr 29, 2014
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K133879 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 130d
Cleared Apr 28, 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · MTD
Boston Scientific Corporation
Cardiovascular · 35d
Cleared Apr 25, 2014
FORA CARE BLOOD PRESSURE MONITORING SYSTEM
K133588 · DXN
Foracare, Inc.
Cardiovascular · 155d
Cleared Apr 25, 2014
GEL-BEAD EMBOLIZATION SPHERES
K133237 · KRD
Vascular Solutions, Inc.
Cardiovascular · 186d
Cleared Apr 24, 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB,...
K140080 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 100d
Cleared Apr 24, 2014
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K131525 · MKJ
Defibtech, LLC
Cardiovascular · 331d
Cleared Apr 23, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K133897 · OGZ
Infraredx, Inc.
Cardiovascular · 124d
Cleared Apr 23, 2014
PATIENT MONITOR
K132077 · MHX
Advanced Instrumentations, Inc.
Cardiovascular · 292d
Cleared Apr 21, 2014
ENVOY GUIDING CATHETER
K140307 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 73d
Cleared Apr 18, 2014
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
K133998 · PNO
Angioscore, Inc.
Cardiovascular · 113d
Cleared Apr 18, 2014
COMPASS CT, COMPASS CT PORT
K133624 · DRS
Mirador Biomedical
Cardiovascular · 143d
Cleared Apr 18, 2014
MCKESSON CARDIOLOGY ECG MOBILE
K133534 · DQK
Mckesson Israel , Ltd.
Cardiovascular · 151d
Cleared Apr 18, 2014
PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND...
K132075 · MHX
Mindray North America
Cardiovascular · 289d
Cleared Apr 17, 2014
ENCORE 26 ADVANTAGE KIT
K140745 · MAV
Boston Scientific Corp
Cardiovascular · 23d
Cleared Apr 17, 2014
DESTINO TWIST, STEERABLE GUIDING SHEATH
K140406 · DYB
Oscor, Inc.
Cardiovascular · 58d
Cleared Apr 17, 2014
INITARY BETTER BLADDER-PEDIATRIC
K140321 · DTN
Circulatory Technology, Inc.
Cardiovascular · 58d
Cleared Apr 17, 2014
FLIP INTRODUCER ACCESS KIT
K132789 · DYB
Vascular Solutions, Inc.
Cardiovascular · 223d