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
5809–5832 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 18, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915,...
K091737 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
DISPOSABLE PRESSURE TRANSDUCER
K091408 · DRS
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 98d
Cleared Aug 13, 2009
CHROMA, MODEL: RZ153C
K083382 · MWJ
Scottcare Corporation
Cardiovascular · 272d
Cleared Aug 12, 2009
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
K092315 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 13d
Cleared Aug 07, 2009
EN SNARE ENDOVASCULAR SNARE SYSTEM
K092343 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 3d
Cleared Aug 07, 2009
TRAILBLAZER SUPPORT CATHETER
K092299 · DQY
Ev3, Inc.
Cardiovascular · 9d
Cleared Aug 07, 2009
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003,...
K092075 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 29d
Cleared Aug 07, 2009
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
K092064 · OBJ
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Aug 07, 2009
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700,...
K091856 · DRX
Conmed Corporation
Cardiovascular · 45d
Cleared Aug 07, 2009
CRYOPATCH SG PULMONARY HEMI-ARTERY
K091626 · DXZ
Cryolife, Inc.
Cardiovascular · 65d
Cleared Aug 07, 2009
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
K091548 · MKJ
Amco International Manufacturing &...
Cardiovascular · 72d
Cleared Aug 07, 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · DQX
Cook, Inc.
Cardiovascular · 89d
Cleared Aug 07, 2009
HORIZON XVU
K091165 · DQK
Mennen Medical , Ltd.
Cardiovascular · 107d
Cleared Aug 07, 2009
SIGNAL
K090493 · DQD
Zargis Medical Corp.
Cardiovascular · 163d
Cleared Aug 04, 2009
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
K091062 · DTN
Gish Biomedical, Inc.
Cardiovascular · 112d
Cleared Jul 31, 2009
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K091500 · DXN
Andon Health Co, Ltd.
Cardiovascular · 71d
Cleared Jul 31, 2009
HERO VASCULAR ACCESS DEVICE
K091491 · DSY
Hemosphere, Inc.
Cardiovascular · 72d
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
K092045 · DXN
Andon Health Co, Ltd.
Cardiovascular · 24d
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962
K091997 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Jul 30, 2009
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
K091966 · PNO
Angioscore, Inc.
Cardiovascular · 29d
Cleared Jul 30, 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
K091961 · DQO
Concentric Medical, Inc.
Cardiovascular · 29d
Cleared Jul 30, 2009
RECRUIT MICROCATHETER
K091563 · MMX
Reverse Medical Corporation
Cardiovascular · 63d
Cleared Jul 30, 2009
NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER
K090918 · DQY
Nfocus Neuromedical, Inc.
Cardiovascular · 120d
Cleared Jul 30, 2009
AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL...
K090867 · DYB
Ep Dynamics, Inc.
Cardiovascular · 121d