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
3241–3264 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 21, 2016
Pantheris Catheter
K160827 · MCW
Avinger, Inc.
Cardiovascular · 27d
Cleared Apr 15, 2016
Bullfrog Micro-Infusion Device
K153501 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 130d
Cleared Apr 14, 2016
The Nanostim Introducer Kit
K160716 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared Apr 14, 2016
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
K153251 · DXQ
Ningbo Free Trade Zone Tenso Medical...
Cardiovascular · 156d
Cleared Apr 13, 2016
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30...
K153038 · MAV
Medtronic, Inc.
Cardiovascular · 177d
Cleared Apr 13, 2016
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
K151953 · DXN
A&D Company, Ltd.
Cardiovascular · 273d
Cleared Apr 12, 2016
HealthChek Network Health Station
K152107 · DXN
Healthchek Network, LLC
Cardiovascular · 258d
Cleared Apr 11, 2016
Map-it Diagnostic Mapping Catheters
K160390 · DRF
Access Point Technologies Ep, Inc.
Cardiovascular · 60d
Cleared Apr 11, 2016
BioMonitor 2-AF, BioMonitor 2-S
K152995 · MXD
Biotronik, Inc.
Cardiovascular · 181d
Cleared Apr 08, 2016
Nihon Kohden Afib Detection Program QP-039P
K152305 · DSI
Nihon Kohden Corporation
Cardiovascular · 238d
Cleared Apr 07, 2016
FIRMap Catheter
K153093 · MTD
Abbott Electrophysiology
Cardiovascular · 164d
Cleared Apr 07, 2016
Merge Hemo
K152864 · DQK
Merge Healthcare Incorporated
Cardiovascular · 190d
Cleared Apr 07, 2016
transGlide Expandable Introducer
K152194 · DYB
Transaortic Medical, Inc.
Cardiovascular · 246d
Cleared Apr 05, 2016
Disposable Temporary Pacing Cable
K152947 · DSA
Tiger Medical Products
Cardiovascular · 182d
Cleared Apr 04, 2016
Hydroven 12, Hydroven 12 Garments
K152228 · JOW
Huntleigh Healthcare , Ltd.
Cardiovascular · 241d
Cleared Apr 01, 2016
PlasmaFlow
K160318 · JOW
Manamed, Inc.
Cardiovascular · 56d
Cleared Apr 01, 2016
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
K152881 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 184d
Cleared Mar 31, 2016
T3 Software
K152258 · PLB
Etiometry, Inc.
Cardiovascular · 233d
Cleared Mar 30, 2016
AVIVO Mobile Patient Management (MPM) System
K153160 · MHX
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 29, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160336 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Mar 25, 2016
DeRoyal Angiography Kits
K152978 · DXT
Deroyal Industries, Inc.
Cardiovascular · 168d
Cleared Mar 23, 2016
Reprocessed Steerable Introducer
K152090 · PNE
Sterilmed, Inc.
Cardiovascular · 240d
Cleared Mar 18, 2016
CorPath 200 System
K152999 · DXX
Corindus, Inc.
Cardiovascular · 157d
Cleared Mar 18, 2016
CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless...
K151499 · DXN
Caretaker Medical, LLC
Cardiovascular · 288d