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
4801–4824 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 29, 2012
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
K120738 · LIT
Ostial Corporation
Cardiovascular · 17d
Cleared Mar 29, 2012
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 29d
Cleared Mar 28, 2012
AZUR DETACHABLE 18
K120630 · KRD
MicroVention, Inc.
Cardiovascular · 27d
Cleared Mar 22, 2012
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
K113798 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 90d
Cleared Mar 22, 2012
INTELLIVUE PATIENT MONITOR
K113657 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 101d
Cleared Mar 22, 2012
PHYSIOLOGICAL MONITOR, PATIENT MONITOR
K113441 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 122d
Cleared Mar 22, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K113220 · LOX
Boston Scientific Corporation
Cardiovascular · 142d
Cleared Mar 22, 2012
EZSLEEP SLEEP QUALITY RECORDER
K112573 · MWJ
Platinum Team Co., Ltd.
Cardiovascular · 198d
Cleared Mar 22, 2012
VISI MOBILE MONITORING SYSTEM
K112478 · MWI
Sotera Wireless, Inc.
Cardiovascular · 206d
Cleared Mar 21, 2012
UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
K112887 · DYB
Upstream Peripheral Technologies
Cardiovascular · 173d
Cleared Mar 21, 2012
ZOLL X SERIES
K112432 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 211d
Cleared Mar 20, 2012
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
K113475 · OCL
Endoscopic Technologies, Inc. D/B/A...
Cardiovascular · 119d
Cleared Mar 20, 2012
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
K112100 · DQY
Vascular Solutions, Inc.
Cardiovascular · 242d
Cleared Mar 19, 2012
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
K120544 · DRF
St Jude Medical
Cardiovascular · 25d
Cleared Mar 16, 2012
GORE(R) EMBOLIC FILTER
K120480 · NTE
W.L. Gore & Associates
Cardiovascular · 29d
Cleared Mar 16, 2012
ELECTROCARDIOGRAPH
K120188 · DPS
Edan Instruments, Inc.
Cardiovascular · 53d
Cleared Mar 16, 2012
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K113811 · DQK
C.R. Bard Inc., Bard...
Cardiovascular · 84d
Cleared Mar 16, 2012
HORIZON CARDIOLOGY ECG MANAGEMENT
K113515 · DQK
Mckesson Israel , Ltd.
Cardiovascular · 109d
Cleared Mar 16, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
K113239 · DXN
Health & Life Co., Ltd.
Cardiovascular · 135d
Cleared Mar 15, 2012
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
K120677 · LIT
Trireme Medical, Inc.
Cardiovascular · 9d
Cleared Mar 15, 2012
CONQUEST 40 PTA DILATATION CATHETER
K120660 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 10d
Cleared Mar 15, 2012
AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH...
K120120 · DQY
Aga Medical Corporation
Cardiovascular · 58d
Cleared Mar 15, 2012
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
K112998 · DRM
Zoll Circulation
Cardiovascular · 160d
Cleared Mar 15, 2012
CONCENTRIC BALLOON GUIDE CATHETER
K112404 · DQY
Concentric Medical, Inc.
Cardiovascular · 206d