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
4561–4584 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 02, 2012
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
K121878 · OCL
Medtronic, Inc.
Cardiovascular · 127d
Cleared Nov 02, 2012
TAMARIN BLUE PTCA RX DILATATION CATHETER
K112735 · LOX
Natec Medical , Ltd.
Cardiovascular · 409d
Cleared Nov 01, 2012
EXTENDED LIFE BATTERY
K120350 · MKJ
Aed Battery Exchange, LLC
Cardiovascular · 269d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · DQX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 26, 2012
ZOLL FULLY AUTOMATIC AED PLUS
K120406 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 260d
Cleared Oct 25, 2012
STEALTH 360 ORBITAL PAD SYSTEM
K122987 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 29d
Cleared Oct 25, 2012
DIGITAL ELECTROCARDIOGRAPH
K122712 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 51d
Cleared Oct 23, 2012
HX-461
K120545 · DXN
Seers Technology Co., Ltd.
Cardiovascular · 243d
Cleared Oct 22, 2012
ATLAS GOLD PTA DILATATION CATHETER
K122984 · LIT
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Oct 22, 2012
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K122482 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 69d
Cleared Oct 22, 2012
CPRMETER CPR FEEDBACK DEVICE
K122050 · LIX
Laerdal Medical A/S
Cardiovascular · 102d
Cleared Oct 19, 2012
JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM...
K122916 · MCW
Medrad, Inc.
Cardiovascular · 28d
Cleared Oct 19, 2012
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
K122913 · DWF
Medtronic, Inc.
Cardiovascular · 28d
Cleared Oct 19, 2012
PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
K121962 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 106d
Cleared Oct 18, 2012
AIRCAST VENAFLOW ELITE SYSTEM
K122499 · JOW
Djo, LLC
Cardiovascular · 63d
Cleared Oct 17, 2012
CHARTER GUIDEWIRE
K122856 · DQX
Brivant, Ltd.
Cardiovascular · 29d
Cleared Oct 17, 2012
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
K122844 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Oct 12, 2012
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
K122811 · DTL
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 11, 2012
CXI SUPPORT CATHETER
K122796 · KRA
Cook, Inc.
Cardiovascular · 29d
Cleared Oct 11, 2012
LIFEPAK 1000 DEFIBRILLATOR
K122600 · MKJ
Physio-Control, Inc.
Cardiovascular · 45d
Cleared Oct 11, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA...
K122178 · LOX
Ostial Corporation
Cardiovascular · 80d
Cleared Oct 11, 2012
ESA620 ELECTRICAL SAFETY ANALYZER
K121722 · DRT
Fluke Biomedical
Cardiovascular · 121d
Cleared Oct 11, 2012
TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X...
K121083 · OZT
Loma Vista Medical
Cardiovascular · 184d
Cleared Oct 10, 2012
NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
K112826 · MUD
Moor Instruments, Ltd.
Cardiovascular · 378d