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
8593–8616 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 13, 2001
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
K013367 · DPS
Reynolds Medical , Ltd.
Cardiovascular · 64d
Cleared Dec 13, 2001
MEDRAD QWIK-FIT SYRINGE
K013815 · DXT
Medrad, Inc.
Cardiovascular · 27d
Cleared Dec 11, 2001
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH...
K010443 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 300d
Cleared Dec 11, 2001
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246 · MSX
Datex-Ohmeda
Cardiovascular · 74d
Cleared Dec 06, 2001
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
K013789 · DQY
Boston Scientific, Target
Cardiovascular · 22d
Cleared Dec 04, 2001
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
K013013 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 88d
Cleared Dec 04, 2001
SELECTIVA GUIDEWIRE
K013024 · DQX
Neometrics, Inc.
Cardiovascular · 88d
Cleared Dec 04, 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · DQY
Guidant Corp.
Cardiovascular · 29d
Cleared Dec 03, 2001
LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
K011144 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 231d
Cleared Dec 03, 2001
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT...
K013624 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Nov 30, 2001
LYMPHA PRESS PLUS DEVICE
K013331 · JOW
Mego Afek
Cardiovascular · 56d
Cleared Nov 29, 2001
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR,...
K013427 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 44d
Cleared Nov 28, 2001
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL...
K013199 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 64d
Cleared Nov 28, 2001
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
K013581 · DQY
Cordis, A Johnson & Johnson Co.
Cardiovascular · 30d
Cleared Nov 26, 2001
COMPRESSIBLE LIMB SLEEVE
K011192 · JOW
Alliance Medical Corp.
Cardiovascular · 221d
Cleared Nov 21, 2001
STENT SUPPORT GUIDE CATHETER
K010579 · DQY
Medtronic Vascular
Cardiovascular · 267d
Cleared Nov 21, 2001
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
K011328 · LOS
Bionet Company, Ltd.
Cardiovascular · 204d
Cleared Nov 21, 2001
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4
K011487 · DXZ
Somanetics Corp.
Cardiovascular · 190d
Cleared Nov 21, 2001
RENAL GUIDING SHEATH
K012854 · DYB
Terumo Medical Corp.
Cardiovascular · 89d
Cleared Nov 21, 2001
CARTO XP EP NAVIGATION SYSTEM
K013083 · DQK
Biosense Webster, Inc.
Cardiovascular · 68d
Cleared Nov 21, 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · DPS
Cambridge Heart, Inc.
Cardiovascular · 26d
Cleared Nov 21, 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K013565 · DPS
Cambridge Heart, Inc.
Cardiovascular · 26d
Cleared Nov 16, 2001
POWERHEART CARDIAC RHYTHM MODULE
K012197 · MKJ
Cardiac Science, Inc.
Cardiovascular · 126d
Cleared Nov 16, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE
K012774 · DWF
Jostra AG
Cardiovascular · 88d