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
4657–4680 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 02, 2012
HEADWAY DUO MICROCATHETER
K120917 · DQO
MicroVention, Inc.
Cardiovascular · 128d
Cleared Aug 02, 2012
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
K120430 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 171d
Cleared Aug 02, 2012
DISITAL BLOOD PRESSURE MONITOR
K112620 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 329d
Cleared Aug 01, 2012
ORION MICRO CATHETER
K113289 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 268d
Cleared Jul 31, 2012
HQS INTRODUCER
K113849 · DYB
Alseal
Cardiovascular · 215d
Cleared Jul 30, 2012
PLATO MICROCATH 27 MICROCATHETER
K121734 · DQO
Scientia Vascular, LLC
Cardiovascular · 47d
Cleared Jul 30, 2012
XPRESSWAY RX CATHETER (6F LD-VERISON)
K121301 · QEZ
Kaneka Pharma America, LLC
Cardiovascular · 90d
Cleared Jul 27, 2012
THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
K121748 · DYB
Access Scientific, Inc.
Cardiovascular · 43d
Cleared Jul 27, 2012
SENSICARDIAC
K121617 · DQD
Diacoustic Medical (Pty)
Cardiovascular · 56d
Cleared Jul 26, 2012
ICP TRIAGEMANAGER
K122095 · DRG
Emergo Europe Consulting BV
Cardiovascular · 14d
Cleared Jul 26, 2012
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL...
K121909 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 27d
Cleared Jul 26, 2012
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K121013 · MWI
Welch Allyn, Inc.
Cardiovascular · 114d
Cleared Jul 26, 2012
ORIGEN REINFORCED DUAL LUMEN CATHETER
K113869 · DWF
Origen Biomedical, Inc.
Cardiovascular · 209d
Cleared Jul 26, 2012
CAREGUIDE OXIMETER
K113656 · MUD
Reflectance Medical, Inc.
Cardiovascular · 227d
Cleared Jul 25, 2012
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA,...
K120988 · DWF
Medtronic, Inc.
Cardiovascular · 114d
Cleared Jul 24, 2012
COMPRESSION CARE FLIGHT
K121376 · JOW
Medical Minds, LLC
Cardiovascular · 77d
Cleared Jul 23, 2012
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL...
K121229 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 90d
Cleared Jul 20, 2012
HYBRID ARCTICGEL PAD
K120849 · DWJ
Medivance, Inc.
Cardiovascular · 122d
Cleared Jul 20, 2012
DISPOSABLE TORQUE DEVICE
K113498 · DQX
Coeur, Inc.
Cardiovascular · 238d
Cleared Jul 20, 2012
SLIDEWIRETM(TRADEMARK PENDING)
K113162 · DQX
Acme-Monaco Corp.
Cardiovascular · 268d
Cleared Jul 19, 2012
RSCRIBE ELECTROCARDIOGRAPH
K120865 · DPS
Mortara Instrument, Inc.
Cardiovascular · 119d
Cleared Jul 19, 2012
CORPATH 200 SYSTEM
K120834 · DXX
Corindus, Inc.
Cardiovascular · 122d
Cleared Jul 19, 2012
PROCARE MONITOR B40
K120598 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 142d
Cleared Jul 19, 2012
HANDHELD ECG MONITOR
K112622 · DPS
Beijing Choice Electronic Technololgy...
Cardiovascular · 315d