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
6865–6888 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 11, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · NFA
Boston Scientific Corp
Cardiovascular · 91d
Cleared Aug 10, 2006
DM-3000 DIGITAL BLOOD PRESSURE MONITOR
K061086 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 114d
Cleared Aug 09, 2006
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
K062126 · DQO
Biosphere Medical, Inc.
Cardiovascular · 14d
Cleared Aug 09, 2006
CARDIODRIVE, MODEL 001-004115 (NON-STERILE)
K042850 · DQY
Stereotaxis, Inc.
Cardiovascular · 663d
Cleared Aug 07, 2006
GORE PRECLUDE VESSEL GUARD
K061727 · MFX
W.L. Gore & Associates, Inc.
Cardiovascular · 49d
Cleared Aug 04, 2006
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00,...
K061963 · DQO
Micrus Endovascular Corporation
Cardiovascular · 23d
Cleared Aug 04, 2006
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS
K061450 · DQE
Hospira, Inc.
Cardiovascular · 71d
Cleared Aug 04, 2006
12 RL ALGORITHM
K060307 · DRT
Ge Medical Systems Information...
Cardiovascular · 178d
Cleared Aug 04, 2006
NAUTIFLUX
K060010 · DQO
Sedat
Cardiovascular · 213d
Cleared Aug 03, 2006
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
K061015 · DYB
St Jude Medical
Cardiovascular · 112d
Cleared Aug 02, 2006
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
K061822 · DXN
Omron Healthcare, Inc.
Cardiovascular · 35d
Cleared Aug 02, 2006
VISION VXC CENTRAL STATION, MODEL 4300
K061675 · MHX
Invivo Corporation
Cardiovascular · 49d
Cleared Aug 02, 2006
LANGSTON DUAL LUMEN CATHETER
K061565 · DQO
Vascular Solutions, Inc.
Cardiovascular · 58d
Cleared Aug 02, 2006
PEPER
K060297 · DXH
Medical Monitors, Ltd.
Cardiovascular · 177d
Cleared Aug 01, 2006
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
K061857 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 32d
Cleared Aug 01, 2006
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K061843 · DQY
St Jude Medical
Cardiovascular · 32d
Cleared Aug 01, 2006
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 61d
Cleared Aug 01, 2006
12SL ECG ANALYSIS PROGRAM
K060833 · MHX
Ge Medical Systems Information...
Cardiovascular · 127d
Cleared Aug 01, 2006
MEDCOMP VASCU-SHEATH II
K053092 · DYB
Medcomp
Cardiovascular · 271d
Cleared Jul 25, 2006
SURGI-CUF REUSABLE, RS SERIES
K061962 · DXQ
Ethox International
Cardiovascular · 13d
Cleared Jul 25, 2006
PULSION PICCO PLUS, MODEL 8100
K060898 · DXG
Pulsion Medical Systems AG
Cardiovascular · 113d
Cleared Jul 21, 2006
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
K061977 · DXH
Pinmed, Inc.
Cardiovascular · 8d
Cleared Jul 21, 2006
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000
K061743 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 30d
Cleared Jul 14, 2006
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER
K061710 · DQY
St Jude Medical
Cardiovascular · 25d