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
3937–3960 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 06, 2014
HANDHELD MONITOR
K131762 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 354d
Cleared Jun 02, 2014
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K140774 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 66d
Cleared Jun 02, 2014
CHOCOLATE PTCA BOLLOON CATHETER
K133633 · LOX
Trireme Medical, Inc.
Cardiovascular · 188d
Cleared May 30, 2014
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K141124 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 29d
Cleared May 30, 2014
BIO-PROBE DISPOSABLE INSERT WITH
K132730 · DPT
Medtronic, Inc.
Cardiovascular · 269d
Cleared May 30, 2014
FAMILY HEALTHWARE
K132173 · DRG
Sanitas, Inc.
Cardiovascular · 319d
Cleared May 28, 2014
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
K133481 · MXC
St. Jude Medical, Inc.
Cardiovascular · 196d
Cleared May 23, 2014
TIGHTRAIL MINI
K141131 · DRE
Spectranetics, Inc.
Cardiovascular · 22d
Cleared May 23, 2014
CORCAM HEART MONITOR
K140548 · DSI
Corcam Technologia, SA
Cardiovascular · 80d
Cleared May 22, 2014
ANS1 SOFTWARE
K140412 · DXN
Ld Technology, LLC
Cardiovascular · 93d
Cleared May 22, 2014
CARPENTIER BI-CAVAL FEMORAL CANNULA
K140192 · DWF
Medtronic, Inc.
Cardiovascular · 115d
Cleared May 22, 2014
ZOLL X SERIES
K133269 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 210d
Cleared May 22, 2014
EV1000 CLINICAL PLATFORM
K131892 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 331d
Cleared May 22, 2014
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K131588 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 356d
Cleared May 21, 2014
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
K140151 · QEY
Btg International, Inc.
Cardiovascular · 119d
Cleared May 21, 2014
CARDIOHELP SYSTEM
K133598 · DTQ
Maquet Cardiopulmonary, AG
Cardiovascular · 180d
Cleared May 20, 2014
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL...
K140165 · DWF
Medtronic, Inc.
Cardiovascular · 118d
Cleared May 19, 2014
INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450,...
K141015 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 28d
Cleared May 19, 2014
VIEWFLEX XTRA ICE CATHETER
K133853 · OBJ
Irvine Biomedical, Inc., A St. Jude...
Cardiovascular · 151d
Cleared May 19, 2014
DMS 300-2W HOLTER ECG RECORDER
K133014 · MWJ
Diagnostic Monitoring Software
Cardiovascular · 236d
Cleared May 16, 2014
APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
K141041 · OTD
Aptus Endosystems
Cardiovascular · 23d
Cleared May 16, 2014
AXERA RX ACCESS SYSTEM
K140287 · DYB
Arstasis, Inc.
Cardiovascular · 100d
Cleared May 16, 2014
TEMPUS PRO EXTENDED FEATURES
K133988 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 141d
Cleared May 16, 2014
VITAL SIGNS MONITOR
K132037 · MWI
Mindray North America
Cardiovascular · 319d