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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10561–10584 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 28, 1995
NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE
K942977 · DYB
Novoste Corp.
Cardiovascular · 556d
Cleared Dec 28, 1995
DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR
K952494 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 212d
Cleared Dec 28, 1995
CORDIS BRITE TIP SHEATH INTRODUCER
K954595 · DYB
Cordis Corp.
Cardiovascular · 86d
Cleared Dec 26, 1995
TRANSPORT CART
K952576 · DSP
Belmont Instrument Corp.
Cardiovascular · 204d
Cleared Dec 26, 1995
DF-1 TERMINAL CAP
K954551 · DTB
Pacesetter, Inc.
Cardiovascular · 85d
Cleared Dec 22, 1995
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
K943896 · DQX
Datascope Corp.
Cardiovascular · 499d
Cleared Dec 22, 1995
Multi Side Hole lnfusion System
K953384 · QEY
AngioDynamics, Inc.
Cardiovascular · 156d
Cleared Dec 22, 1995
ROTABLATOR ROTATIONAL ANGIOPLASTY
K953997 · MCW
Heart Technology Mfg., Inc.
Cardiovascular · 120d
Cleared Dec 22, 1995
TRANSIT INFUSION CATHETER WITH SIDEHOLES
K954949 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 53d
Cleared Dec 21, 1995
CORDIS WESTER STAR CATHETER
K954390 · DRF
Cordis Webster, Inc.
Cardiovascular · 93d
Cleared Dec 21, 1995
CARTO SYSTEM
K954395 · DQK
Biosense, Ltd.
Cardiovascular · 92d
Cleared Dec 20, 1995
COURIER BALLOON DILATATION CATHETER
K953569 · LIT
Boston Scientific Corp
Cardiovascular · 142d
Cleared Dec 20, 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K953608 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 140d
Cleared Dec 19, 1995
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293 · DSY
Vascutek, Ltd.
Cardiovascular · 217d
Cleared Dec 19, 1995
CARDIOVIT AT-1C, AT-2C
K953396 · LOS
Schiller America, Inc.
Cardiovascular · 152d
Cleared Dec 15, 1995
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866 · DXY
Medtronic Vascular
Cardiovascular · 127d
Cleared Dec 15, 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092 · DXY
Medtronic Vascular
Cardiovascular · 127d
Cleared Dec 13, 1995
THE NINER NITINOL GUIDEWIRE
K952860 · DQX
Microvena Corp.
Cardiovascular · 174d
Cleared Dec 13, 1995
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
K954809 · LDF
Medtronic Vascular
Cardiovascular · 55d
Cleared Dec 12, 1995
DISPOSABLE ECG MONITORING ELECTRODE
K950473 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 312d
Cleared Dec 07, 1995
ACS TOURGIDE GUIDING CATHETER
K953987 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 106d
Cleared Dec 07, 1995
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582 · DSY
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared Dec 05, 1995
LIFE SOUND SENSOR AMPLIFIER-LISA
K953833 · DQD
Flowscan, Inc.
Cardiovascular · 112d
Cleared Dec 01, 1995
FOCUS PC BALLOON DILATATION CATHETER
K954313 · LIT
Cardio-Dynamics, Inc.
Cardiovascular · 77d