FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
11977–12000 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 31, 1991
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451 · DSI
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Oct 31, 1991
QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE
K914672 · DRX
Medicotest, Inc.
Cardiovascular · 13d
Cleared Oct 28, 1991
ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR
K911965 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 179d
Cleared Oct 28, 1991
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
K912604 · KFM
Aries Medical, Inc.
Cardiovascular · 150d
Cleared Oct 28, 1991
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE
K913631 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 74d
Cleared Oct 28, 1991
DAIG FAST CATH(TM) INTRODUCER, MODIFICATION
K914090 · DYB
Daig Corp.
Cardiovascular · 47d
Cleared Oct 25, 1991
TORQUE TUBE STEEROCATH(TM)
K913375 · DRF
Ep Technologies, Inc.
Cardiovascular · 88d
Cleared Oct 23, 1991
HEPARIN COATED THERMODILUTION CATH & ACCESSORIES
K911710 · DQO
Sunscope Intl., Inc.
Cardiovascular · 189d
Cleared Oct 23, 1991
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY
K912079 · DTZ
3M Health Care, Sarns
Cardiovascular · 166d
Cleared Oct 23, 1991
UNIPOLAR UPSIZING ADAPTOR
K912773 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 121d
Cleared Oct 23, 1991
OCHSNER ULP BIFURCATION VASCULAR PROTHESIS
K913143 · DSY
Intervascular, Inc.
Cardiovascular · 99d
Cleared Oct 23, 1991
.010 HI-TORQUE PLUS(TM) GUIDE WIRE
K913328 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Oct 23, 1991
VASCULAR GUIDE WIRE
K913353 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 89d
Cleared Oct 23, 1991
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER
K913734 · DWJ
Augustine Medical, Inc.
Cardiovascular · 64d
Cleared Oct 23, 1991
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER
K914141 · DQO
Cordis Corp.
Cardiovascular · 37d
Cleared Oct 21, 1991
MERIT MANIFOLD
K913161 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 96d
Cleared Oct 18, 1991
ANNULUS DISPOSABLE VALVULOTOME
K912635 · MGZ
Cardio Source
Cardiovascular · 126d
Cleared Oct 18, 1991
ANNULUS VALVULOTOME
K912636 · MGZ
Cardio Source
Cardiovascular · 126d
Cleared Oct 18, 1991
CORDIS PTCA GUIDING CATHETER, MODIFICATION
K913783 · DQY
Dow Corning Wright
Cardiovascular · 65d
Cleared Oct 18, 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007 · DQO
Cordis Corp.
Cardiovascular · 39d
Cleared Oct 17, 1991
SIMON NITINOL FILTER, MODIFICATION
K912144 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 157d
Cleared Oct 17, 1991
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
K913288 · DTB
Medtronic Vascular
Cardiovascular · 85d
Cleared Oct 16, 1991
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
K905403 · DXY
Cook Pacemaker Corp.
Cardiovascular · 317d
Cleared Oct 16, 1991
CARD GUARD, MODELS CG-6000 & CG-7000
K910884 · DSH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 226d