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
9649–9672 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 27, 1998
PIOLAX HYDROPHILIC GUIDEWIRE
K980977 · DQX
Piolax Medical Devices, Inc.
Cardiovascular · 225d
Cleared Oct 26, 1998
COBE SMARXT TUBING AND CONNECTORS
K981613 · DWE
Cobe Cardiovascular, Inc.
Cardiovascular · 173d
Cleared Oct 21, 1998
DOCKING-EXTENSION WIRE
K982592 · DQX
Schneider (Europe) GmbH
Cardiovascular · 89d
Cleared Oct 21, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
K982896 · LDD
Alexander Mfg. Co.
Cardiovascular · 65d
Cleared Oct 19, 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · DQO
Daig Corp.
Cardiovascular · 110d
Cleared Oct 16, 1998
ENVY GUIDING CATHETER
K974774 · DQO
Cook, Inc.
Cardiovascular · 298d
Cleared Oct 16, 1998
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660 · DSP
C.R. Bard, Inc.
Cardiovascular · 158d
Cleared Oct 15, 1998
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · DTD
Medtronic Vascular
Cardiovascular · 113d
Cleared Oct 14, 1998
VGF-7 VASCULAR GRAFT FLOWMETER
K973198 · DPW
Medicard , Ltd.
Cardiovascular · 414d
Cleared Oct 14, 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713 · DQX
C.R. Bard, Inc.
Cardiovascular · 301d
Cleared Oct 14, 1998
CARDIOPAL MODEL NUMBER PM20
K981119 · DXH
Medicomp, Inc.
Cardiovascular · 201d
Cleared Oct 14, 1998
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K981697 · DPS
Cambridge Heart, Inc.
Cardiovascular · 156d
Cleared Oct 14, 1998
ECG ELECTRODES APRON
K982470 · DRX
Tapuz Medical Technology , Ltd.
Cardiovascular · 90d
Cleared Oct 09, 1998
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814 · DXT
Medrad, Inc.
Cardiovascular · 59d
Cleared Oct 07, 1998
ZYMED TELEMETRY SYSTEM
K980186 · DSI
Agilent Technologies
Cardiovascular · 260d
Cleared Oct 07, 1998
COBE VACUUM RELIEF CHECK VALVE
K982406 · MJJ
Cobe Cardiovascular, Inc.
Cardiovascular · 89d
Cleared Oct 06, 1998
QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)
K981024 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 201d
Cleared Oct 02, 1998
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
K982538 · DSP
Belmont Instrument Corp.
Cardiovascular · 73d
Cleared Oct 01, 1998
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K983023 · DYB
Cordis Corp.
Cardiovascular · 31d
Cleared Sep 30, 1998
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
K982891 · DTS
California Medical Laboratories, Inc.
Cardiovascular · 44d
Cleared Sep 25, 1998
PRESS-MATE ADVANTAGE
K973637 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 366d
Cleared Sep 25, 1998
VITAL SIGNS MONITOR
K982279 · MHX
Bci Intl., Inc.
Cardiovascular · 87d
Cleared Sep 25, 1998
A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR
K982481 · DXN
A&D Engineering, Inc.
Cardiovascular · 71d
Cleared Sep 23, 1998
EWC: ECG CABLE AND LEADWIRE SYSTEMS
K982817 · DSA
Ewc
Cardiovascular · 43d