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
5857–5880 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 30, 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · MUD
Nonin Medical, Inc.
Cardiovascular · 97d
Cleared Jun 22, 2009
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
K091593 · QEZ
Possis Medical, Inc.
Cardiovascular · 20d
Cleared Jun 19, 2009
JETSTREAM G2 NXT SYSTEM, MODEL PV20300
K091509 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 28d
Cleared Jun 19, 2009
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION...
K091504 · MJN
Micrus Endovascular Corporation
Cardiovascular · 29d
Cleared Jun 19, 2009
VASCUTEK BRANCHED GELWEAVE
K090987 · DSY
Vascutek, Ltd.
Cardiovascular · 73d
Cleared Jun 19, 2009
NUVANT CARDIAC EVENT MONITORING SYSTEM
K090696 · QYX
Corventis, Inc.
Cardiovascular · 95d
Cleared Jun 19, 2009
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
K090621 · DXT
Flowcardia, Inc.
Cardiovascular · 102d
Cleared Jun 19, 2009
SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500,...
K083753 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 184d
Cleared Jun 18, 2009
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS...
K091449 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 31d
Cleared Jun 18, 2009
PIGGYBACK WIRE CONVERTER
K090977 · DQY
Vascular Solutions, Inc.
Cardiovascular · 73d
Cleared Jun 18, 2009
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
K080941 · DSB
N.I. Medical, Ltd.
Cardiovascular · 441d
Cleared Jun 17, 2009
LUCAS 2
K090422 · DRM
Jolife AB
Cardiovascular · 119d
Cleared Jun 17, 2009
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
K090180 · DRX
Vermed, Inc.
Cardiovascular · 145d
Cleared Jun 16, 2009
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL...
K090721 · OCL
Medtronic
Cardiovascular · 90d
Cleared Jun 15, 2009
DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K081259 · MKJ
Defibtech, LLC
Cardiovascular · 409d
Cleared Jun 12, 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K091527 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared Jun 12, 2009
GOPHER GOLD CATHETER, MODEL 5620
K091345 · DQY
Vascular Solutions, Inc.
Cardiovascular · 37d
Cleared Jun 12, 2009
FLOCONTROL , MODEL 1028
K090970 · MJN
Coaxia, Inc.
Cardiovascular · 67d
Cleared Jun 12, 2009
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL...
K090511 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 106d
Cleared Jun 10, 2009
COR12+
K091505 · DSH
Viasys Healthcare GmbH
Cardiovascular · 20d
Cleared Jun 08, 2009
CAPIOX BUBBLE TRAP WITH X-COATING
K090698 · KRL
Terumo Cardiovascular Systems
Cardiovascular · 83d
Cleared Jun 05, 2009
MP5 INTELLIVUE PATIENT MONITOR
K091395 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 25d
Cleared Jun 05, 2009
RADIA STEERABLE DIAGNOSTIC CATHETER
K091370 · DRF
C.R. Bard, Inc.
Cardiovascular · 28d
Cleared Jun 05, 2009
PLANET 55, MODEL 100
K090443 · MHX
Larsen & Toubro Limited
Cardiovascular · 105d