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
4537–4560 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 20, 2012
PENUMBRA DDC CATHETERS
K122772 · DQY
Penumbra, Inc.
Cardiovascular · 71d
Cleared Nov 20, 2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573 · DQX
Abbott Vascular, Inc.
Cardiovascular · 89d
Cleared Nov 20, 2012
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
K122488 · DXX
Catheter Robotics, Inc.
Cardiovascular · 97d
Cleared Nov 20, 2012
UFIT TEN-10
K122443 · DXN
Biosign Technologies, Inc.
Cardiovascular · 102d
Cleared Nov 20, 2012
ZOLL RESCUENET 12-LEAD
K121865 · MSX
ZOLL Medical Corporation
Cardiovascular · 147d
Cleared Nov 20, 2012
AIRSTRIP RPM FOR LIFENET CONSULT
K121712 · MSX
Airstrip Technologies, Inc.
Cardiovascular · 162d
Cleared Nov 20, 2012
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
K121234 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 210d
Cleared Nov 19, 2012
ALIVECOR HEART MONITOR FOR IPHONE
K122356 · DPS
AliveCor, Inc.
Cardiovascular · 108d
Cleared Nov 19, 2012
MOBILECARE MONITOR
K122333 · DRG
Aframe Digital, Inc.
Cardiovascular · 109d
Cleared Nov 19, 2012
PTFE SUPER SHEATH INTRODUCER
K120617 · DYB
Martech Medical Products
Cardiovascular · 264d
Cleared Nov 16, 2012
SPHYGMOCOR XCEL
K122129 · DXN
Atcor Medical
Cardiovascular · 121d
Cleared Nov 15, 2012
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
K122090 · MXC
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 122d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214 · MAV
Boston Scientific Corp
Cardiovascular · 29d
Cleared Nov 13, 2012
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K120857 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 237d
Cleared Nov 13, 2012
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
K112830 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 412d
Cleared Nov 09, 2012
AIR-BAND RADIAL COMPRESSION DEVICE
K122405 · DXC
Datascope Corp., Cardiac Assist Division
Cardiovascular · 94d
Cleared Nov 09, 2012
ALN OPTIONAL VANA CAVA FILTER
K113124 · DTK
Aln Implants Chirurgicaux
Cardiovascular · 385d
Cleared Nov 08, 2012
STINGRAY GUIDEWIRES
K122795 · DQX
Bridgepoint Medical
Cardiovascular · 57d
Cleared Nov 07, 2012
OCELOT SYSTEM
K122380 · PDU
Avinger, Inc.
Cardiovascular · 93d
Cleared Nov 07, 2012
CLEARLUMEN THROMBECTOMY SYSTEM
K120508 · QEZ
Walk Vascular, LLC
Cardiovascular · 260d
Cleared Nov 07, 2012
COMEN MULTI-PARAMETER PATIENT MONITOR
K112877 · MWI
Goldway Us, Inc.
Cardiovascular · 404d
Cleared Nov 05, 2012
FLEXIPORT ECOCUFF
K122058 · DXQ
Welch Allyn, Inc.
Cardiovascular · 115d
Cleared Nov 02, 2012
TANGO M2 BLOOD PRESSURE MONITOR
K122401 · DXN
Suntech Medical, Inc.
Cardiovascular · 87d
Cleared Nov 02, 2012
BARD PTV DILATATION CATHETER
K122367 · OMZ
C.R. Bard, Inc.
Cardiovascular · 88d