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
3529–3552 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 11, 2015
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation...
K142468 · DSH
Cardiac Insight, Inc.
Cardiovascular · 311d
Cleared Jul 07, 2015
ANGIO-PRESS DVT Compression Device Model Name: IPCS
K143202 · JOW
Pegasus Medical Supply, Inc.
Cardiovascular · 242d
Cleared Jul 06, 2015
Armada 18 PTA Catheter
K151317 · LIT
Abbott Vascular
Cardiovascular · 49d
Cleared Jul 06, 2015
Hypervisor IX Monitoring System
K150632 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 117d
Cleared Jul 02, 2015
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
K151254 · DSP
Datascope Corp.
Cardiovascular · 51d
Cleared Jul 02, 2015
ECVUE Mapping System
K150990 · DQK
Cardioinsight Technologies, Inc.
Cardiovascular · 78d
Cleared Jul 02, 2015
AUTOMATIC BLOOD PRESSURE MONITOR
K140762 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 462d
Cleared Jul 01, 2015
EN Snare Endovascular Snare System
K151497 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Jul 01, 2015
Magellan Robotic System, Magellan Robotic Catheter 10Fr
K143227 · DXX
Hansen Medical, Inc.
Cardiovascular · 233d
Cleared Jun 30, 2015
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
K151290 · DXQ
Xuzhou Maicuff Technology Co., Ltd.
Cardiovascular · 46d
Cleared Jun 30, 2015
AGE Automatic Wrist Blood Pressure Monitor
K151281 · DXN
Dongguan Ageless Health Industrial...
Cardiovascular · 47d
Cleared Jun 30, 2015
Aneroid Sphygmomanometer
K151246 · DXQ
Jiaxing Zhongfa Medical Products Co.,...
Cardiovascular · 50d
Cleared Jun 30, 2015
Sensis
K150493 · DQK
Siemens Medi Cal Solutions, Inc.
Cardiovascular · 125d
Cleared Jun 30, 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 130d
Cleared Jun 28, 2015
FILAO NC RX PTCA DILATATION CATHETER
K141933 · LOX
Natec Medical , Ltd.
Cardiovascular · 347d
Cleared Jun 26, 2015
ADH 200 Analyzer Software
K143449 · DQK
Adams Meditech, LLC
Cardiovascular · 206d
Cleared Jun 26, 2015
Plato MICROCATH 27B Microcatheter
K143398 · DQO
Scientia Vascular, LLC
Cardiovascular · 212d
Cleared Jun 25, 2015
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and...
K150975 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 73d
Cleared Jun 25, 2015
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular...
K143604 · DQO
Alvimedica Tibbi Urunler Sanayi VE...
Cardiovascular · 189d
Cleared Jun 25, 2015
DuraSheath Introducer Sheath System
K142357 · DYB
Contract Medical International, GmbH
Cardiovascular · 304d
Cleared Jun 24, 2015
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
K143093 · LIT
Hotspur Technologies, Inc.,
Cardiovascular · 239d
Cleared Jun 23, 2015
ASAHI Corsair Microcatheter
K151103 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Jun 23, 2015
Flowtron ACS900
K143438 · JOW
Getinge (Suzhou) Co., Ltd.
Cardiovascular · 203d
Not Cleared Jun 23, 2015
ESOPHAGEAL COOLING DEVICE
DEN140018 · PLA
Advanced Cooling Therapy, LLC
Cardiovascular · 410d