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
7729–7752 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 26, 2004
CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
K040252 · MCW
Rex Medical
Cardiovascular · 22d
Cleared Feb 25, 2004
GOLDWAY UT4000A VITAL SIGNS MONITOR
K033988 · MWI
Goldway Us, Inc.
Cardiovascular · 64d
Cleared Feb 24, 2004
CREATION NM DIAGNOSTIC CATHETERS
K032888 · DQO
Neich Medical (Shenzhen) Company Limited
Cardiovascular · 161d
Cleared Feb 24, 2004
CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG...
K033030 · MWI
Witt Biomedical Corp
Cardiovascular · 151d
Cleared Feb 24, 2004
SKINTACT ECG ELECTRODE
K040249 · DRX
Leonhard Lang GmbH
Cardiovascular · 21d
Cleared Feb 24, 2004
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
K040309 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Feb 23, 2004
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034,...
K033678 · DQY
Spectranetics Corp.
Cardiovascular · 91d
Cleared Feb 19, 2004
GELSOFT PLUS ERS
K034010 · DSY
Vascutek, Ltd.
Cardiovascular · 57d
Cleared Feb 18, 2004
VASCON POLARIS GUIDING CATHETER
K033633 · DQY
Vascon, LLC
Cardiovascular · 91d
Cleared Feb 18, 2004
ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
K040139 · KRA
Endobionics, Inc.
Cardiovascular · 27d
Cleared Feb 18, 2004
MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K040150 · DYB
Medamicus, Inc.
Cardiovascular · 26d
Cleared Feb 13, 2004
ECHO SOUNDER EX-101EX 8 MHZ
K031931 · DPW
Koven Technology, Inc.
Cardiovascular · 235d
Cleared Feb 13, 2004
NOVOSCI READY SYSTEM, MODEL RS-200
K033270 · KFM
Novosci Corp.
Cardiovascular · 126d
Cleared Feb 13, 2004
WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES
K033615 · JOW
Wheaton Franciscan Services Inc.,...
Cardiovascular · 88d
Cleared Feb 13, 2004
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
K034036 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 46d
Cleared Feb 13, 2004
VICEROY INFLATION DEVICE
K040138 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Feb 13, 2004
BARD ATLAS PTA BALLOON DILATATION CATHETER
K040243 · DQY
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Feb 12, 2004
IQ GUIDE WIRE
K040140 · DQX
Boston Scientific Corp
Cardiovascular · 21d
Cleared Feb 11, 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · DXN
Omron Healthcare, Inc.
Cardiovascular · 201d
Cleared Feb 11, 2004
TRIO MONITOR MODEL 0998-00-0600
K032338 · MWI
Datascope Corp.
Cardiovascular · 197d
Cleared Feb 10, 2004
POLARCATH PERIPHERAL DILATATION SYSTEM
K033622 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 84d
Cleared Feb 10, 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800 · DTN
Terumo Cardiovascular Systems...
Cardiovascular · 67d
Cleared Feb 05, 2004
HEARTRAK SMART AT/HEARTRAK SMART2
K033451 · DXH
Universal Medical, Inc.
Cardiovascular · 98d
Cleared Feb 05, 2004
INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
K033527 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d