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
14161–14184 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 25, 1986
D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM
K863230 · DXG
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Nov 25, 1986
D100 COMPUTER CARDIAC ANALYSIS SYSTEM
K863231 · DXG
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Nov 25, 1986
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Nov 25, 1986
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
K864506 · DSI
Spacelabs, Inc.
Cardiovascular · 11d
Cleared Nov 24, 1986
URESIL CAROTID SHUNT
K863558 · DWF
Uresil Corp.
Cardiovascular · 73d
Cleared Nov 24, 1986
DAIG TYPE O4 VS-1 CONNECTOR
K863921 · DTB
Daig Corp.
Cardiovascular · 47d
Cleared Nov 24, 1986
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
K864461 · DWS
Medsurg Industries, Inc.
Cardiovascular · 12d
Cleared Nov 24, 1986
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
K864505 · DSI
Spacelabs, Inc.
Cardiovascular · 10d
Cleared Nov 21, 1986
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
K863366 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Nov 21, 1986
LIFE-WATCH MONITOR LT-8
K863534 · DRT
Computerized Medical Systems, Inc.
Cardiovascular · 71d
Cleared Nov 20, 1986
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858 · LYK
Olympus Corp.
Cardiovascular · 258d
Cleared Nov 20, 1986
CASE 12
K862316 · DSI
Marquette Electronics, Inc.
Cardiovascular · 155d
Cleared Nov 20, 1986
630C ELECTROCARDIOGRAPH
K863030 · DPS
Quinton, Inc.
Cardiovascular · 101d
Cleared Nov 20, 1986
TERUMO RADIFOCUS GUIDE WIRE
K863138 · DQX
Terumo Medical Corp.
Cardiovascular · 97d
Cleared Nov 20, 1986
CLAMPEASE FA
K863427 · DXC
Freund Medical Products
Cardiovascular · 77d
Cleared Nov 20, 1986
CHIN-FOGARTY INFLATION DEVICE
K863596 · DXT
American Edwards Laboratories
Cardiovascular · 66d
Cleared Nov 20, 1986
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K863724 · DSI
Oxford Medilog, Inc.
Cardiovascular · 58d
Cleared Nov 20, 1986
EM III DISPOSABLE ELECTRODE
K863845 · DRX
Electromed Intl., Ltd.
Cardiovascular · 50d
Cleared Nov 20, 1986
MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
K864002 · DTB
Intermedics, Inc.
Cardiovascular · 37d
Cleared Nov 20, 1986
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
K864155 · DTJ
American Edwards Laboratories
Cardiovascular · 28d
Cleared Nov 20, 1986
MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD
K864287 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 18, 1986
FORTEC MI-100, BLOOD PRESSURE METER
K862200 · DSK
Fortec Electronic Corp./Nam Tai
Cardiovascular · 161d
Cleared Nov 18, 1986
MODIFIED SARNS OXYGENATOR SYSTEM
K863515 · DTZ
3M Health Care, Sarns
Cardiovascular · 69d
Cleared Nov 18, 1986
STOCKERT-SHILEY CAPS HLM INTERFACE
K863541 · DTQ
Shiley, Inc.
Cardiovascular · 68d