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
3625–3648 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 09, 2015
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
K150567 · DWF
Medtronic, Inc.
Cardiovascular · 34d
Cleared Apr 09, 2015
Chocolate PTCA Balloon Catheter
K150292 · LOX
Trireme Medical, LLC
Cardiovascular · 62d
Cleared Apr 09, 2015
Prelude SNAP Splittable Sheath Introducer
K143255 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 147d
Cleared Apr 08, 2015
AngioSculpt PTA Scoring Baloon Catheters
K150634 · PNO
Spectranetrics
Cardiovascular · 28d
Cleared Apr 03, 2015
V8 Transluminal BAV Catheter
K150343 · OZT
Intervalve, Inc.
Cardiovascular · 51d
Cleared Apr 03, 2015
Crux Vena Cava Filter System, femoral
K150262 · DTK
Volcano Corporation
Cardiovascular · 58d
Cleared Apr 03, 2015
Digital Automatic Wrist Blood Pressure Monitor MD2400
K143733 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 94d
Cleared Apr 03, 2015
ELECTRONIC BLOOD PRESSURE MONITOR
K141683 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 284d
Cleared Apr 02, 2015
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307,...
K150545 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 30d
Cleared Apr 02, 2015
Disposable Blood Pressure Cuff Guard
K150227 · DXQ
Pinhu Sama Medical Packing Co., Ltd.
Cardiovascular · 59d
Cleared Apr 02, 2015
Euphora Rapid Exchange Balloon Dilatation Catheter
K143480 · LOX
Medtronic, Inc.
Cardiovascular · 115d
Cleared Apr 02, 2015
AWARE
K143372 · MWI
Ambient Clinical Analytics
Cardiovascular · 128d
Cleared Apr 01, 2015
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology...
K150631 · DRF
St Jude Medical
Cardiovascular · 21d
Cleared Apr 01, 2015
Silk Road Acccess Catheter
K143459 · DQY
Silk Road Medical, Inc.
Cardiovascular · 118d
Cleared Apr 01, 2015
125mL CT Syringe
K142745 · DXT
Coeur, Inc.
Cardiovascular · 189d
Cleared Mar 30, 2015
Ebony PTA 0.035 Peripheral Dilatation Catheter
K143036 · LIT
Natec Medical , Ltd.
Cardiovascular · 159d
Cleared Mar 29, 2015
eMotion Faros ECG Mobile
K143032 · DXH
Mega Electronics , Ltd.
Cardiovascular · 158d
Cleared Mar 27, 2015
SOFIA 6F Catheter
K150366 · DQY
MicroVention, Inc.
Cardiovascular · 43d
Cleared Mar 27, 2015
HealthGuard-15
K143108 · DXN
Futrex, Inc.
Cardiovascular · 149d
Cleared Mar 27, 2015
samaritan PAD 450P
K142709 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 186d
Cleared Mar 27, 2015
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · PNO
Cook Incorporated
Cardiovascular · 311d
Cleared Mar 26, 2015
AVERT Contrast Modulation System
K150485 · DXT
Osprey Medical, Inc.
Cardiovascular · 30d
Cleared Mar 26, 2015
Headway 27 Microcatheter
K142449 · DQY
MicroVention, Inc.
Cardiovascular · 205d
Cleared Mar 25, 2015
Bio-Medicus Pediatric Cannula and Introducers
K143083 · DWF
Medtronic, Inc.
Cardiovascular · 149d