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
5425–5448 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 06, 2010
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
K101647 · DQY
Avinger, Inc.
Cardiovascular · 56d
Cleared Aug 06, 2010
STINGRAY ORIENTING BALLOON CATHETER
K101591 · DQY
Bridgepoint Medical
Cardiovascular · 60d
Cleared Aug 06, 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542 · DQY
MicroVention, Inc.
Cardiovascular · 64d
Cleared Aug 06, 2010
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0
K100376 · MSX
Earlysense, Ltd.
Cardiovascular · 175d
Cleared Aug 04, 2010
REEFLEX PTA CATHETER
K101361 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 82d
Cleared Aug 04, 2010
CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
K101198 · DXN
Computerized Screening, Inc.
Cardiovascular · 97d
Cleared Aug 02, 2010
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
K100819 · DYB
Onset Medical Corporation
Cardiovascular · 132d
Cleared Jul 30, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008
K101010 · DXN
Andon Health Co, Ltd.
Cardiovascular · 109d
Cleared Jul 29, 2010
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
K101521 · MHX
Philips Medical Systems
Cardiovascular · 57d
Cleared Jul 29, 2010
ZOLL PROPAQ MD
K100654 · LDD
Zoll Medical Corporation, World Wide...
Cardiovascular · 143d
Cleared Jul 28, 2010
HYDROFIX VASO SHIELD, MODEL HVS-001-0610
K101826 · OMR
Mimedx Group, Inc.
Cardiovascular · 27d
Cleared Jul 28, 2010
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K101615 · PDU
Baylis Medical Co., Inc.
Cardiovascular · 49d
Cleared Jul 23, 2010
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
K101866 · DXZ
Cryolife, Inc.
Cardiovascular · 21d
Cleared Jul 23, 2010
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · PDU
Medtronic Vascular
Cardiovascular · 28d
Cleared Jul 23, 2010
SCOUTPRO ACS
K101776 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Jul 23, 2010
REPROCESSED COMPRESSION SLEEVES
K100909 · JOW
Ascent Healthcare Solutions
Cardiovascular · 113d
Cleared Jul 23, 2010
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
K100813 · DPS
Pulse Biomedical, Inc.
Cardiovascular · 122d
Cleared Jul 23, 2010
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE,...
K100133 · MWI
Airstrip Technologies, LP
Cardiovascular · 185d
Cleared Jul 22, 2010
SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
K101972 · DXQ
Solaris Medical Technology, Inc.
Cardiovascular · 9d
Cleared Jul 22, 2010
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
K101576 · DRX
Team Innovations, Inc.
Cardiovascular · 45d
Cleared Jul 22, 2010
YRNSORTIP OXIMANOMETER
K093981 · DXN
Cnoga Medical , Ltd.
Cardiovascular · 210d
Cleared Jul 21, 2010
GLIDESHEATH
K102008 · DYB
Terumo Medical Corp.
Cardiovascular · 5d
Cleared Jul 21, 2010
WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0
K101674 · MWI
Athena Gtx
Cardiovascular · 36d
Cleared Jul 21, 2010
SCOUTPRO HEMOSTATIC VALVE
K101282 · DQY
Biotronik, Inc.
Cardiovascular · 76d