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
7585–7608 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 09, 2004
BIOPORE BALLOON DILATION CATHETER
K041293 · LIT
Bipore, Inc.
Cardiovascular · 56d
Cleared Jul 07, 2004
CMI MAGNETOCARDIOGRAPH
K033488 · DPS
Cmi Cardiomag Imaging, Inc.
Cardiovascular · 246d
Cleared Jul 02, 2004
MYSHELL
K040498 · DTL
Sedat S.A.
Cardiovascular · 127d
Cleared Jul 02, 2004
STOCKERTIR PURGE CONTROL (APC) SYSTEM
K041558 · DTW
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared Jul 01, 2004
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
K022823 · MGZ
Geister Medizin Technik GmbH
Cardiovascular · 675d
Cleared Jul 01, 2004
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
K032937 · DXX
Stereotaxis, Inc.
Cardiovascular · 283d
Cleared Jul 01, 2004
PERIPHERAL CUTTING BALLOON
K040155 · PNO
Boston Scientific Corp
Cardiovascular · 160d
Cleared Jul 01, 2004
POWERHEART AED G3A
K040438 · MKJ
Cardiac Science, Inc.
Cardiovascular · 133d
Cleared Jul 01, 2004
LIFEPAK 12 DEFIBRILLATOR/MONITOR
K041459 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 29d
Cleared Jun 30, 2004
H-FLOW VALVE
K034043 · DQO
Elcam Medical Acal
Cardiovascular · 184d
Cleared Jun 30, 2004
TELENABLE EMS SYSTEM
K040663 · DRG
Molex, Inc.
Cardiovascular · 110d
Cleared Jun 30, 2004
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K041686 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 8d
Cleared Jun 28, 2004
SCD EXPRESS PORTABLE COMPRESSION SYSTEM
K040511 · JOW
Tyco Healthcare/Kendall
Cardiovascular · 122d
Cleared Jun 28, 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026 · DRX
Ambu, Inc.
Cardiovascular · 68d
Cleared Jun 28, 2004
REMOTENURSE PATIENT MONITORING SYSTEM
K041308 · DXH
Webvmc, LLC
Cardiovascular · 42d
Cleared Jun 22, 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
K033464 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 235d
Cleared Jun 22, 2004
VITALHEAT
K040911 · DWJ
Dynatherm Medical, Inc.
Cardiovascular · 75d
Cleared Jun 21, 2004
CONCENTRIC RETRIEVER X5, MODEL 90035
K040700 · DQY
Concentric Medical, Inc.
Cardiovascular · 96d
Cleared Jun 18, 2004
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
K040728 · DYB
AngioDynamics, Inc.
Cardiovascular · 88d
Cleared Jun 18, 2004
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · DXC
Vascular Solutions, Inc.
Cardiovascular · 88d
Cleared Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · DQO
NuMED, Inc.
Cardiovascular · 79d
Cleared Jun 18, 2004
STABIL-O-GRAPH
K041313 · DXN
I.E.M. GmbH
Cardiovascular · 32d
Cleared Jun 16, 2004
DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100...
K033896 · MKJ
Defibtech, LLC
Cardiovascular · 183d
Cleared Jun 10, 2004
R-TEST EVOLUTION 3
K040753 · MLO
Novacor
Cardiovascular · 78d