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
4753–4776 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 16, 2012
PATIENT MONITOR
K120173 · MHX
Edan Instruments, Inc.
Cardiovascular · 117d
Cleared May 16, 2012
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K112921 · DSI
Medicalgorithmics S.A.
Cardiovascular · 226d
Cleared May 15, 2012
TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
K121141 · DXN
Tensys Medical Systems, Inc.
Cardiovascular · 29d
Cleared May 15, 2012
SWITCH-IT CATHETER
K120707 · DQY
Vascular Solutions, Inc.
Cardiovascular · 68d
Cleared May 14, 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
K113266 · KRD
Vascular Solutions, Inc.
Cardiovascular · 192d
Cleared May 14, 2012
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · MUD
Nonin Medical, Inc.
Cardiovascular · 195d
Cleared May 11, 2012
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
K120296 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 101d
Cleared May 11, 2012
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
K120185 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 109d
Cleared May 11, 2012
SUNMED GUIDE WIRE
K120119 · DQX
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 115d
Cleared May 10, 2012
POCKETCPR
K112660 · LIX
Zoll Medical Corp
Cardiovascular · 240d
Cleared May 08, 2012
TERUMO PALL AL20X ARTERIAL FILTER
K121209 · DTM
Terumo Cardiovascular Systems...
Cardiovascular · 18d
Cleared May 08, 2012
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
K120298 · DQX
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 98d
Cleared May 08, 2012
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
K120072 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 119d
Cleared May 07, 2012
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
K120550 · DQK
Biosense Webster, Inc.
Cardiovascular · 74d
Cleared May 04, 2012
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
K121057 · DTK
William Cook Europe Aps
Cardiovascular · 28d
Cleared May 04, 2012
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K121015 · NTE
Abbott Vascular
Cardiovascular · 30d
Cleared May 04, 2012
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 88d
Cleared May 04, 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · LIT
Cordis Corp.
Cardiovascular · 221d
Cleared May 03, 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · MTD
St Jude Medical
Cardiovascular · 30d
Cleared May 03, 2012
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
K120704 · DRG
3M Company
Cardiovascular · 56d
Cleared May 01, 2012
VITAL SIGNS MONITOR
K113833 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 126d
Cleared Apr 30, 2012
K2 MEDICAL VASCULAR CLAMPS
K120492 · DXC
K2 Medical GmbH & Co. KG
Cardiovascular · 73d
Cleared Apr 25, 2012
ELECTROCARDIOGRAPH
K113485 · DPS
Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular · 154d
Cleared Apr 25, 2012
ZOLL PROPAQ MD
K112761 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 216d