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
3553–3576 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 19, 2015
PreludeEASE Hydrophilic Sheath Introducer
K150257 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 136d
Cleared Jun 19, 2015
ZIO SR ECG Monitoring Service
K143513 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 190d
Cleared Jun 17, 2015
ProTrack RF Anchor Wire
K150709 · DXF
Baylis Medical Company, Inc.
Cardiovascular · 90d
Cleared Jun 17, 2015
True Dilatation Balloon Valvuloplasty Catheter
K150667 · OZT
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Jun 17, 2015
STAR 90
K150512 · MWI
Skanray Technologies Pvt, Ltd.
Cardiovascular · 110d
Cleared Jun 17, 2015
Vdrive system, Vdrive Duo, Vdrive with V-Sono
K150312 · DXX
Stereotaxis, Inc.
Cardiovascular · 128d
Cleared Jun 15, 2015
XXL Vascular Balloon Dilatation Catheter
K150303 · LIT
Boston Scientific Corp
Cardiovascular · 129d
Cleared Jun 12, 2015
Opto Wire and OptoMonitor System
K142598 · DQX
Opsens, Inc.
Cardiovascular · 270d
Cleared Jun 11, 2015
Pre-Formed Guidewire
K151244 · DQX
Lake Region Medical
Cardiovascular · 31d
Cleared Jun 11, 2015
EOS PMP, EOS PMP Integrated
K150489 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 106d
Cleared Jun 11, 2015
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.:...
K150373 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 118d
Cleared Jun 11, 2015
Personalized Physiology Analytics Engine software
K142512 · PLB
Vgbio, Inc (Dba Physiq)
Cardiovascular · 276d
Cleared Jun 10, 2015
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy...
K151260 · MCW
Cardiovascular System, Inc.
Cardiovascular · 29d
Cleared Jun 10, 2015
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
K151253 · PNO
Boston Scientific Limited
Cardiovascular · 29d
Cleared Jun 07, 2015
MicroCross Catheter
K151082 · DQY
Roxwood Medical, Inc.
Cardiovascular · 46d
Cleared Jun 05, 2015
Chariot Guiding Sheath
K150186 · DYB
Boston Scientific Corp
Cardiovascular · 129d
Cleared Jun 05, 2015
IMED-Z FLUID STATUS MONITOR
K142503 · DSB
Intersection Medical, Inc.
Cardiovascular · 273d
Cleared Jun 04, 2015
WIRION
K143570 · NTE
Gardia Medical
Cardiovascular · 169d
Cleared Jun 04, 2015
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire...
K143041 · LIT
Natec Medical , Ltd.
Cardiovascular · 225d
Cleared Jun 03, 2015
Cardio-TriTest
K143432 · DPS
Cardio-Phoenix, Inc.
Cardiovascular · 184d
Cleared May 31, 2015
Occlusion Balloon Catheter
K142692 · MJN
Embolx, Inc.
Cardiovascular · 251d
Cleared May 28, 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · DQX
Cook Incorporated
Cardiovascular · 63d
Cleared May 28, 2015
PTA 14 Balloon Dilatation Catheter OTW
K142954 · LIT
Texasmedical Technologies, Inc.
Cardiovascular · 230d
Cleared May 27, 2015
Intersept Filtered Cardiotomy Reservoir
K151110 · DTN
Medtronic, Inc.
Cardiovascular · 30d