FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15505–15528 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 18, 1984
BUSH NECK W/TAP
K841410 · DRM
Warne Surgical Products, Ltd.
Cardiovascular · 13d
Cleared Apr 17, 1984
DIGITAL SPHYGMOMANOMETER UA-251
K832722 · DXN
Copal, Inc.
Cardiovascular · 249d
Cleared Apr 17, 1984
DIGITAL SPHGMOMANOMETER UA-271
K832723 · DXN
Copal, Inc.
Cardiovascular · 249d
Cleared Apr 17, 1984
RESPIRATION/8100-HEART RATE RECORDER
K833348 · DSH
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Apr 17, 1984
EVENT TAPE RECORDER 8293
K833349 · DSH
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Apr 17, 1984
CONTRAST MEDIA INJECT. SET CMS
K833645 · DXT
Gish Biomedical, Inc.
Cardiovascular · 183d
Cleared Apr 17, 1984
ISOTEC DISPOS. PRESSURE TRANSDUCER
K833884
Delta Medical Industries
Cardiovascular · 160d
Cleared Apr 17, 1984
SARNS 8.0 SOFT ARC CANNULA
K834134 · DWF
3M Health Care, Sarns
Cardiovascular · 139d
Cleared Apr 17, 1984
HOLTER CARDIOGRAPHY SYS 6201
K834397 · DSI
Instruments For Cardiac Research
Cardiovascular · 125d
Cleared Apr 17, 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · DSI
Spacelabs, Inc.
Cardiovascular · 109d
Cleared Apr 17, 1984
MICROFUSE INTRAVENOUS CATHETER SET
K840240 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 88d
Cleared Apr 17, 1984
MINI-DEFIBRILLATOR 280/4
K840246 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 96d
Cleared Apr 17, 1984
CARDIOFAX ECG 6543
K840274 · DRS
Nihon Kohden America, Inc.
Cardiovascular · 85d
Cleared Apr 17, 1984
ANGIOGRAPHIC DRAPE PACKS
K840281 · DXT
Medrad, Inc.
Cardiovascular · 85d
Cleared Apr 17, 1984
SHILEY PREBYPASS FILTER
K840450 · KRJ
Shiley, Inc.
Cardiovascular · 76d
Cleared Apr 17, 1984
NEONATAL PHYSIOLOGICAL MONITOR 903
K840560 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 69d
Cleared Apr 17, 1984
PEDIATRIC ARTERIAL BLOOD FILTER
K840612 · DTM
American Bentley
Cardiovascular · 64d
Cleared Apr 17, 1984
GAST STAT MONITORING SYSTEM
K840749 · DTY
Cardiovascular Devices, Inc.
Cardiovascular · 54d
Cleared Apr 17, 1984
ARGYLE TAPERED VASCULAR SHUNT
K840914 · DWF
Sherwood Medical Co.
Cardiovascular · 48d
Cleared Apr 17, 1984
ANGIOGRAPHY NEEDLE W/WO CONNECTION
K840923 · DYB
Dlp, Inc.
Cardiovascular · 46d
Cleared Apr 17, 1984
HOLDER FOR MODELS AF-10,1025,1040,5
K841032 · KRI
American Bentley
Cardiovascular · 36d
Cleared Apr 17, 1984
PRESSURE MANOMETER
K841071 · DQX
Interventional Medical, Inc.
Cardiovascular · 36d
Cleared Apr 17, 1984
WILLIAM HARVEY H-4700 FILTER/CARDIO
K841079 · DTN
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Apr 17, 1984
MINI PECG-MODIFICATION
K841148 · DPS
Intersect Systems, Inc.
Cardiovascular · 27d