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
6193–6216 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 27, 2008
ROLL-X GUIDEWIRE
K082304 · DQX
St Jude Medical
Cardiovascular · 14d
Cleared Aug 27, 2008
CURBELL PATIENT MONITORING CABLES
K081762 · DSA
Curbell Electronics, Inc.
Cardiovascular · 68d
Cleared Aug 27, 2008
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K080861 · MJN
Micrus Endovascular Corporation
Cardiovascular · 153d
Cleared Aug 26, 2008
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
K082173 · DPS
Cardiac Science Corporation
Cardiovascular · 25d
Cleared Aug 25, 2008
MICRO GUIDE CATHETER XP
K082143 · PDU
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 22, 2008
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
K081983 · MHX
Philips Medical Systems
Cardiovascular · 42d
Cleared Aug 22, 2008
CYGNUS 12 LEAD ECG MODULE
K072950 · KRE
Cygnus, LLC
Cardiovascular · 309d
Cleared Aug 19, 2008
CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
K082191 · NQH
Cardiomems, Inc.
Cardiovascular · 15d
Cleared Aug 19, 2008
INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
K082061 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 29d
Cleared Aug 19, 2008
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · NTE
Abbott Laboratories
Cardiovascular · 77d
Cleared Aug 19, 2008
AXIUM DETACHABLE COIL SYSTEM
K081465 · KRD
Micro Therapeutics, Inc.
Cardiovascular · 84d
Cleared Aug 15, 2008
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
K082075 · DRE
Hansen Medical, Inc.
Cardiovascular · 23d
Cleared Aug 15, 2008
ANEROID SPHYGMOMANOMETER, MODEL KT-A01
K081951 · DXQ
Wenzhou Kindcare Import & Export Co.,...
Cardiovascular · 37d
Cleared Aug 15, 2008
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A...
K081365 · MXC
St Jude Medical
Cardiovascular · 92d
Cleared Aug 15, 2008
TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX
K080189 · DXQ
Trimline Medical Products Corp.
Cardiovascular · 203d
Cleared Aug 14, 2008
MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K081944 · MCW
Cardio Systems, Inc.
Cardiovascular · 37d
Cleared Aug 12, 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
K080637 · DQX
Stereotaxis, Inc.
Cardiovascular · 159d
Cleared Aug 11, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K082059 · PNO
Angioscore, Inc.
Cardiovascular · 21d
Cleared Aug 11, 2008
FINDRWIRZ GUIDE WIRE SYSTEM
K080364 · DQX
Sentreheart, Inc.
Cardiovascular · 182d
Cleared Aug 08, 2008
APPROACH CTO WIRE GUIDE
K081337 · DQX
Cook Incorporated
Cardiovascular · 87d
Cleared Aug 08, 2008
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK...
K081159 · DXN
Harvard Medical Devices , Ltd.
Cardiovascular · 116d
Cleared Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · DQX
Boston Scientific Corp
Cardiovascular · 120d
Cleared Aug 08, 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · KRA
Cook, Inc.
Cardiovascular · 144d
Cleared Aug 05, 2008
PIONEER PLUS CATHETER
K081804 · PDU
Medtronic, Inc.
Cardiovascular · 40d