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
6145–6168 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 10, 2008
TEMPUSIC PATIENT MONITOR
K082718 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 23d
Cleared Oct 10, 2008
HEM-9000AI
K081654 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Oct 08, 2008
SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS...
K082280 · MHX
Philips Medical Systems North America...
Cardiovascular · 58d
Cleared Oct 08, 2008
ICON, MODEL C3
K082242 · DSB
Osypka Medical, Inc.
Cardiovascular · 62d
Cleared Oct 08, 2008
BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE,...
K081187 · DQX
Bridgepoint Medical
Cardiovascular · 163d
Cleared Oct 06, 2008
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
K082664 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 24d
Cleared Oct 06, 2008
LYMPHA PRESS OPTIMAL, MODEL# 1201AP
K082149 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 68d
Cleared Oct 06, 2008
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR,...
K081820 · DWF
Avalon Laboratories, LLC
Cardiovascular · 101d
Cleared Oct 03, 2008
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30,...
K082633 · DSI
Philips Medizinsysteme Boeblingen...
Cardiovascular · 23d
Cleared Oct 03, 2008
QUART ARTERIAL FILTER WITH BIOLINE COATING
K082544 · DTM
Maquet Cardiopulmonary, AG
Cardiovascular · 30d
Cleared Oct 03, 2008
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
K081933 · DWF
Avalon Laboratories, LLC
Cardiovascular · 88d
Cleared Oct 03, 2008
GORE TRI-LOBE BALLOON CATHETER
K081799 · DQY
W.L. Gore & Associates, Inc.
Cardiovascular · 100d
Cleared Oct 02, 2008
LBI EMBOLECTOMY SYSTEM
K080901 · QEW
Lumen Biomedical, Inc.
Cardiovascular · 185d
Cleared Oct 02, 2008
6F PROXIS SYSTEM
K073700 · DQY
St. Jude Medical, Inc.
Cardiovascular · 276d
Cleared Sep 26, 2008
GALAXY 55
K082685 · MWI
Larsen & Toubro Limited
Cardiovascular · 11d
Cleared Sep 26, 2008
MINI GHOST, MODEL: 507
K082524 · DQY
NuMED, Inc.
Cardiovascular · 24d
Cleared Sep 26, 2008
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · KRA
Terumo Medical Corp.
Cardiovascular · 24d
Cleared Sep 26, 2008
LIFEBED PATIENT VIGILANCE SYSTEM
K082366 · DRT
Hoana Medical, Inc.
Cardiovascular · 39d
Cleared Sep 26, 2008
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
K082256 · MWI
Integrated Medical Systems, Inc.
Cardiovascular · 49d
Cleared Sep 26, 2008
MODIFICATION TO FETCH ASPIRATION CATHETER
K081989 · QEZ
Possis Medical, Inc.
Cardiovascular · 74d
Cleared Sep 26, 2008
ACUNAV V ULTRASOUND CATHETER
K081808 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 92d
Cleared Sep 26, 2008
FLOWPICC STYLET
K081625 · OBJ
Vasonova, Inc.
Cardiovascular · 108d
Cleared Sep 26, 2008
HANDHELD ECG MONITOR, MODEL MD100
K080933 · DPS
Beijing Choice Electronic Technololgy...
Cardiovascular · 177d
Cleared Sep 26, 2008
DUOFLO CATHETER
K080700 · MJN
Thermopeutix, Inc.
Cardiovascular · 199d