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
6601–6624 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 13, 2007
POLARCATH PERIPHERAL DILATATION SYSTEM
K071042 · LIT
Boston Scientific Corp
Cardiovascular · 62d
Cleared Jun 13, 2007
PRONTO .035 EXTRACTION CATHETER
K070403 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 121d
Cleared Jun 13, 2007
STRIDE MICROCATHETER
K062885 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 260d
Cleared Jun 08, 2007
MASIMO PATIENT SAFETY NET
K071047 · MSX
Masimo Corporation
Cardiovascular · 56d
Cleared Jun 08, 2007
PORTACLAMP FLEX
K070380 · DXC
Cardio Life Research, S.A.
Cardiovascular · 120d
Cleared Jun 07, 2007
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K070395 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 118d
Cleared Jun 07, 2007
HEALTH CHECK KIOSK
K063008 · DXN
Xperex Corporation
Cardiovascular · 248d
Cleared Jun 05, 2007
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981,...
K070417 · DYB
St Jude Medical
Cardiovascular · 113d
Cleared Jun 04, 2007
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH...
K070951 · PNO
Boston Scientific
Cardiovascular · 61d
Cleared Jun 04, 2007
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
K070566 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 96d
Cleared Jun 01, 2007
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL...
K070372 · DQY
Vascular Solutions, Inc.
Cardiovascular · 113d
Cleared May 30, 2007
CARDIOMEM CM 3000-12BT
K063042 · MWJ
Getemed Medizin- Und...
Cardiovascular · 239d
Cleared May 25, 2007
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
K071075 · DXN
Terumo Corp.
Cardiovascular · 39d
Cleared May 25, 2007
LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
K070825 · DXN
Little Doctor (Shanghai) Electronic...
Cardiovascular · 60d
Cleared May 25, 2007
AUTO DETECT FOR TELAHEART DR200/E-A
K070014 · MWJ
North East Monitoring, Inc.
Cardiovascular · 142d
Cleared May 24, 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
K070456 · DQO
Micrus Endovascular Corporation
Cardiovascular · 97d
Cleared May 24, 2007
OSTIAL PRO STENT POSITIONING SYSTEM
K062192 · DQX
Ostial Solutions, LLC
Cardiovascular · 297d
Cleared May 23, 2007
BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
K070473 · DXN
Zen Strong Medical Technology Co., Ltd.
Cardiovascular · 92d
Cleared May 22, 2007
WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
K071040 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 40d
Cleared May 22, 2007
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45,...
K070396 · DYB
Acumen Medical, Inc.
Cardiovascular · 99d
Cleared May 22, 2007
BIO-CONSOLE, MODEL 560
K070286 · DWA
Medtronic
Cardiovascular · 113d
Cleared May 17, 2007
EDAC QUANTIFIER
K071231 · KRL
Luna Innovations, Inc.
Cardiovascular · 14d
Cleared May 16, 2007
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
K071189 · LIT
Cordis Europa, N.V.
Cardiovascular · 16d
Cleared May 15, 2007
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
K070242 · OBJ
Biosense Webster, Inc.
Cardiovascular · 95d