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
4393–4416 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 05, 2013
MERIT HYDROPHILIC GUIDE WIRE
K130588 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Apr 05, 2013
ISOLATOR LINEAR PEN
K130521 · OCL
AtriCure, Inc.
Cardiovascular · 36d
Cleared Apr 01, 2013
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
K123733 · OCL
Medtronic, Inc.
Cardiovascular · 117d
Cleared Apr 01, 2013
NMI COAXIAL MICROINTRODUCER SET
K123445 · DRE
Navilyst Medical, Inc.
Cardiovascular · 144d
Cleared Mar 28, 2013
QUANTIEN MEASUREMENT SYSTEM
K123984 · DQK
Radi Medical Systems AB
Cardiovascular · 92d
Cleared Mar 28, 2013
CARDIOMEM
K122272 · MWJ
Getemed Medizin- Und...
Cardiovascular · 241d
Cleared Mar 27, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
K123762 · DWF
Medtronic, Inc.
Cardiovascular · 110d
Cleared Mar 24, 2013
AXERA 2 ACCESS SYSTEM
K123618 · DYB
Arstasis, Inc.
Cardiovascular · 121d
Cleared Mar 22, 2013
MORTARA SURVEYOR PATIENT MONITOR
K123556 · MHX
Mortara Instrument, Inc.
Cardiovascular · 123d
Cleared Mar 22, 2013
FEMORAL ACCESS VENOUS CANNULAE
K123303 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Mar 22, 2013
PROCARE MONITOR B20
K122253 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 238d
Cleared Mar 21, 2013
BP652N (HEM-6300-Z)
K123498 · DXN
Omron Healthcare, Inc.
Cardiovascular · 128d
Cleared Mar 21, 2013
APPS-HEALTH01
K122098 · DXN
Andon Health Co, Ltd.
Cardiovascular · 248d
Cleared Mar 20, 2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR,...
K130433 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 27d
Cleared Mar 20, 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
LIDCORAPID V2 MONITOR
K122247 · DXG
Lidco, Ltd.
Cardiovascular · 236d
Cleared Mar 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
K123765 · DQY
Boston Scientific
Cardiovascular · 102d
Cleared Mar 19, 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K123477 · KRA
Sequent Medical, Inc.
Cardiovascular · 126d
Cleared Mar 19, 2013
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM
Medtronic Perfusion Systems
Cardiovascular · 139d
Cleared Mar 19, 2013
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
K122940 · DQY
Cook, Inc.
Cardiovascular · 176d
Cleared Mar 15, 2013
FLIXENE IFG VASCULAR GRAFT
K130142 · DSY
Atrium Medical Corporation
Cardiovascular · 52d
Cleared Mar 15, 2013
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
K123298 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 143d
Cleared Mar 15, 2013
TVC IMAGING SYSTEM MODEL NIRS-MC7-70
K123108 · OGZ
Infraredx, Inc.
Cardiovascular · 163d