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
8233–8256 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 25, 2002
MEDCOMP VASCU-SHEATH INTRODUCER SET
K022513 · DYB
Medcomp
Cardiovascular · 87d
Cleared Oct 24, 2002
CARDIO ID+(RZ153+)
K022540 · DSH
Rozinn Electronics, Inc.
Cardiovascular · 84d
Cleared Oct 24, 2002
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
K023223 · DQY
Lumend, Inc.
Cardiovascular · 27d
Cleared Oct 24, 2002
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 8d
Cleared Oct 22, 2002
SMITHWICK CAROTID SHUNT
K021608 · DXC
Implantable Devices
Cardiovascular · 159d
Cleared Oct 22, 2002
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED...
K022450 · DTZ
Dideco S.P.A.
Cardiovascular · 88d
Cleared Oct 22, 2002
BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200
K023055 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 39d
Cleared Oct 18, 2002
AROX 45-JBP
K023099 · DTB
Biotronik, Inc.
Cardiovascular · 30d
Cleared Oct 18, 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · DTK
Cordis Corp.
Cardiovascular · 29d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE,...
K022357 · DQX
Boston Scientific, Target
Cardiovascular · 89d
Cleared Oct 16, 2002
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K022754 · DXC
S & T AG
Cardiovascular · 58d
Cleared Oct 11, 2002
REPROCESSED IMAGING CATHETERS
K012537 · OWQ
Sterilmed, Inc.
Cardiovascular · 430d
Cleared Oct 11, 2002
NEICH NM ADVANCE CATHETER SHEATH INTRODUCER
K020964 · DYB
Neich Medical(Shenzhen)Company, Ltd.
Cardiovascular · 200d
Cleared Oct 11, 2002
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300
K021087 · DQD
Erecords Limited
Cardiovascular · 191d
Cleared Oct 11, 2002
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM)...
K022117 · DRC
Merit Medical Systems, Inc.
Cardiovascular · 102d
Cleared Oct 11, 2002
STOCKERT CORONARY PERFUSION CANNULAE
K022280 · DWF
Stockert Instrumente GmbH
Cardiovascular · 88d
Cleared Oct 10, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K022316 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 85d
Cleared Oct 09, 2002
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
K022238 · DWS
Medtronic Vascular
Cardiovascular · 90d
Cleared Oct 09, 2002
STOCKERT V172-28 VENOUS FEMORAL CANNULA
K022321 · DWF
Stockert Instrumente GmbH
Cardiovascular · 84d
Cleared Oct 04, 2002
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
K022210 · MKJ
Cardiac Science, Inc.
Cardiovascular · 88d
Cleared Oct 04, 2002
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006...
K022257 · DRC
Vomed Volzer Medizintechnik GmbH & Co.
Cardiovascular · 84d
Cleared Oct 03, 2002
RADIANALYZER, MODEL 12710
K022188 · DQK
Radi Medical Systems AB
Cardiovascular · 90d
Cleared Oct 03, 2002
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485 · MHX
Datex-Ohmeda
Cardiovascular · 66d
Cleared Oct 03, 2002
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND...
K022939 · DTE
Osypka Medical, Inc.
Cardiovascular · 29d