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
5689–5712 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 04, 2009
UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
K092514 · DXN
Hangzhou Hua'An Medical & Health...
Cardiovascular · 109d
Cleared Dec 04, 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582 · DQX
Medtronic Vascular
Cardiovascular · 185d
Cleared Dec 04, 2009
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
K091352 · OBJ
Biosense Webster, Inc.
Cardiovascular · 211d
Cleared Dec 03, 2009
ZOLL E SERIES WITH SPCO/SPMET OPTION
K092598 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 101d
Cleared Dec 01, 2009
JETSTREAM G3 SYSTEM
K093456 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 26d
Cleared Nov 27, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962,...
K093387 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Nov 27, 2009
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD...
K093359 · DXN
Shanghai Little Doctor Co. Limited
Cardiovascular · 30d
Cleared Nov 27, 2009
CERNER CAREAWARE IBUS
K093134 · DRG
Cerner Corp.
Cardiovascular · 53d
Cleared Nov 24, 2009
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
K093501 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 12d
Cleared Nov 24, 2009
NBP CUFF
K092999 · DXQ
Draeger Medical AG & Co. KG
Cardiovascular · 57d
Cleared Nov 20, 2009
SCOUTPRO 7F LONG CATHETERS
K093303 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared Nov 20, 2009
MICRUS MICROCATHETER, MODEL COURIER 270
K092702 · DQO
Micrus Endovascular Corporation
Cardiovascular · 79d
Cleared Nov 20, 2009
SKYLINE 55, MODEL VER 1
K092153 · MWI
Larsen & Toubro Limited
Cardiovascular · 127d
Cleared Nov 19, 2009
RADAR VASCULAR COMPRESSION DEVICES
K092503 · DXC
Advanced Vascular Dynamics
Cardiovascular · 97d
Cleared Nov 17, 2009
CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
K093389 · DXN
Computerized Screening, Inc.
Cardiovascular · 18d
Cleared Nov 16, 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
K092163 · DXN
Health & Life Co., Ltd.
Cardiovascular · 123d
Cleared Nov 13, 2009
POWERCROSS .018 OTW PTA DILATION CATHETER
K093286 · LIT
Ev3, Inc.
Cardiovascular · 24d
Cleared Nov 13, 2009
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
K091176 · MSX
Philips Medical Systems
Cardiovascular · 205d
Cleared Nov 06, 2009
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · MCW
Ev3, Inc.
Cardiovascular · 16d
Cleared Nov 06, 2009
ENVOY GUIDING CATHETERS
K093184 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Nov 05, 2009
HEADWAY 21 MICROCATHETER, MODEL: MC212150S
K093160 · DQY
MicroVention, Inc.
Cardiovascular · 30d
Cleared Nov 05, 2009
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
K092463 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 86d
Cleared Nov 05, 2009
MODIFICATION TO MODIFIED HD GUIDE CATHETER
K092298 · DQY
Concentric Medical, Inc.
Cardiovascular · 99d
Cleared Nov 05, 2009
GDS-DCS
K091367 · DYB
Guided Delivery Systems
Cardiovascular · 181d