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
5713–5736 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 04, 2009
ENGAGE TR INTRODUCER
K093130 · DYB
St Jude Medical
Cardiovascular · 30d
Cleared Nov 04, 2009
GATOR CLIPSEAL PLUG
K092563 · DTL
Vascular Solutions, Inc.
Cardiovascular · 76d
Cleared Nov 04, 2009
GUIDELINER CATHETER, MODELS 5571, 5572, 5573
K091750 · DQY
Vascular Solutions, Inc.
Cardiovascular · 141d
Cleared Nov 03, 2009
MODEL 220 PATIENT MAGNET
K092364 · DTG
Cyberonics, Inc.
Cardiovascular · 90d
Cleared Nov 03, 2009
INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
K091927 · DSI
Philips Medizinsysteme Boeblingen...
Cardiovascular · 126d
Cleared Nov 02, 2009
SPECTRANETICS VISISHEATH DILATOR SHEATH
K092378 · DRE
Spectranetics Corp.
Cardiovascular · 89d
Cleared Oct 30, 2009
F.A.S.T. SYSTEM SED AND CXD
K092623 · QEW
Genesis Medical Interventional, Inc.
Cardiovascular · 65d
Cleared Oct 29, 2009
PTFE PEELABLE INTRODUCER
K093023 · DYB
Great Batch Medical
Cardiovascular · 30d
Cleared Oct 29, 2009
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
K092361 · LIT
Invatec S.P.A.
Cardiovascular · 86d
Cleared Oct 29, 2009
QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH...
K090689 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 227d
Cleared Oct 28, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35,...
K093002 · KRD
MicroVention, Inc.
Cardiovascular · 30d
Cleared Oct 28, 2009
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100
K092245 · DXQ
Honsun (Nantong) Co., Ltd.
Cardiovascular · 92d
Cleared Oct 27, 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Oct 26, 2009
INSTRUMED VASCULAR CLAMPS
K092544 · DXC
Instrumed International, Inc.
Cardiovascular · 68d
Cleared Oct 26, 2009
SAVI WIRELESS, MODEL PM500
K091696 · DRG
Medicomp, Inc.
Cardiovascular · 138d
Cleared Oct 23, 2009
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
K092456 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 74d
Cleared Oct 22, 2009
PC ECG, MODEL SE-1010
K092010 · DPS
Edan Instruments, Inc.
Cardiovascular · 108d
Cleared Oct 21, 2009
LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND...
K092604 · DXQ
Trimline Medical Products Corp.
Cardiovascular · 57d
Cleared Oct 21, 2009
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
K092425 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 75d
Cleared Oct 21, 2009
VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
K091414 · DXN
Biocare Corp.
Cardiovascular · 161d
Cleared Oct 20, 2009
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
K091542 · DWF
Endoscopic Technologies, Inc. D/B/A...
Cardiovascular · 147d
Cleared Oct 19, 2009
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K092895 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Oct 19, 2009
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER,...
K090487 · DXT
Coeur, Inc.
Cardiovascular · 236d
Cleared Oct 16, 2009
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
K092913 · JOQ
Ep Medsystems
Cardiovascular · 24d