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
3745–3768 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 04, 2014
VESOFLOW PLUS DVT COMPRESSION DEVICE
K141064 · JOW
Caremed Supply, Inc.
Cardiovascular · 224d
Cleared Dec 03, 2014
M3290B Philips IntelliVue Information Center iX
K143057 · MSX
Philips Medical Systems
Cardiovascular · 40d
Cleared Dec 03, 2014
ZOLL X Series
K142915 · MKJ
ZOLL Medical Corporation
Cardiovascular · 57d
Cleared Dec 03, 2014
AliveCor Heart Monitor
K142672 · DXH
AliveCor, Inc.
Cardiovascular · 75d
Cleared Dec 03, 2014
MAC 800 Resting ECG Analysis System
K142288 · DPS
Ge Medical Systems China Co., Ltd.
Cardiovascular · 107d
Cleared Dec 03, 2014
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
K141529 · DQY
Alvimedica Tibbi Urunler Sanayi VE...
Cardiovascular · 177d
Cleared Dec 03, 2014
SURVEYOR S4 MOBILE MONITOR
K141020 · DRG
Mortara Instrument, Inc.
Cardiovascular · 226d
Cleared Dec 03, 2014
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
K133924 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 345d
Cleared Dec 02, 2014
Skintact, various other tradenames
K142803 · MKJ
Leonhard Lang GmbH
Cardiovascular · 64d
Cleared Dec 02, 2014
MEDUSA VASCULAR PLUG,
K140796 · KRD
Endoshape, Inc.
Cardiovascular · 246d
Cleared Dec 02, 2014
CLEARLUMEN THROMBECTOMY SYSTEM
K140296 · QEZ
Walk Vascular, LLC
Cardiovascular · 299d
Cleared Dec 01, 2014
BP652N (HEM-6300-Z)
K142917 · DXN
Omron Healthcare, Inc.
Cardiovascular · 55d
Cleared Dec 01, 2014
SIVR56-T KIT
K133994 · DXJ
Barco N.V.
Cardiovascular · 340d
Not Cleared Nov 26, 2014
HEARTFLOW FFRCT
DEN130045 · PJA
Heartflow
Cardiovascular · 387d
Cleared Nov 25, 2014
VASCU-GUARD Peripheral Vascular Patch
K142461 · DXZ
Synovis Life Technologies, Inc.
Cardiovascular · 84d
Cleared Nov 25, 2014
DR300 HOLTER MONITOR
K142424 · MWJ
North East Monitoring, Inc.
Cardiovascular · 88d
Cleared Nov 25, 2014
Masimo Root Monitoring System and Accesories
K142394 · MWI
Masimo Corporation
Cardiovascular · 90d
Cleared Nov 25, 2014
PREDICATE III GUIDEWIRE
K142393 · DQX
Lake Region Medical
Cardiovascular · 90d
Cleared Nov 25, 2014
TURNPIKE CATHETER
K142065 · DQY
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Nov 25, 2014
GENESIS TOUCH SYSTEM
K141792 · DRG
Honeywell Hommed
Cardiovascular · 146d
Cleared Nov 25, 2014
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
K141231 · MKJ
Zeller Power Products (Battery Beast,...
Cardiovascular · 196d
Cleared Nov 25, 2014
TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III...
K140768 · DYB
Lepu Medical Technology (Bejing) Co.,...
Cardiovascular · 243d
Cleared Nov 25, 2014
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K133989 · DXN
Mortara Instrument, Inc.
Cardiovascular · 334d
Cleared Nov 24, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K141682 · OGZ
Infraredx, Inc.
Cardiovascular · 154d