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
3769–3792 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 21, 2014
ZEUS (ZIO ECG Utilization Service) System
K142681 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 63d
Cleared Nov 21, 2014
GLIDESHEATH SLENDER
K142183 · DYB
Terumo Medical Corporation
Cardiovascular · 105d
Cleared Nov 21, 2014
LG SMARTHEALTH
K133997 · DRG
Lg Electronics
Cardiovascular · 329d
Cleared Nov 20, 2014
Gel-Block 10X embolization pledgets
K143038 · KRD
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Nov 20, 2014
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K142062 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 113d
Cleared Nov 19, 2014
MORTARA MONITORING WAVEFORM VIEWER
K141811 · MHX
Mortara Instrument, Inc.
Cardiovascular · 135d
Cleared Nov 19, 2014
ZOLL X SERIES
K141774 · MKJ
ZOLL Medical Corporation
Cardiovascular · 140d
Cleared Nov 19, 2014
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K141755 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 142d
Cleared Nov 19, 2014
CENTERCROSS CATHETER
K140910 · DQY
Roxwood Medical, Inc.
Cardiovascular · 224d
Cleared Nov 19, 2014
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
K140569 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 258d
Cleared Nov 19, 2014
ECVUE MAPPING SYSTEM
K140497 · DQK
Cardioinsight Technologies, Inc.
Cardiovascular · 265d
Cleared Nov 18, 2014
Bio-Medicus Adult Cannulae and Introducer
K142673 · DWF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Nov 18, 2014
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K141390 · JOW
Wuhan Landing Medical Hi-Tech, Ltd.
Cardiovascular · 175d
Cleared Nov 14, 2014
Panorama Patient Monitoring Network
K142601 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 64d
Cleared Nov 14, 2014
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior...
K142565 · DQY
Stryker Neurovascular
Cardiovascular · 63d
Cleared Nov 14, 2014
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K141617 · QEW
Rex Medical, L.P.
Cardiovascular · 150d
Cleared Nov 14, 2014
MICRO GUIDE CATHETER ELITE
K140438 · PDU
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 266d
Cleared Nov 14, 2014
TECOTHERM NEO (T NEO)
K140078 · DWJ
Inspiration Healthcare, Ltd.
Cardiovascular · 305d
Cleared Nov 13, 2014
ONE Snare Endovascular Microsnare System
K142265 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Nov 13, 2014
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS...
K142254 · DQX
St Jude Medical
Cardiovascular · 91d
Cleared Nov 13, 2014
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS...
K140466 · DXO
St. Jude Medical Systems AB
Cardiovascular · 262d
Cleared Nov 12, 2014
AngioVac Cannula
K142593 · DWF
AngioDynamics, Inc.
Cardiovascular · 58d
Cleared Nov 12, 2014
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator...
K142301 · DRE
Cook Vascular, Inc.
Cardiovascular · 86d
Cleared Nov 06, 2014
FlexCath Select Steerable Sheath (10 French)
K142684 · DYB
Medtronic Cryocath, LP
Cardiovascular · 48d