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
4585–4608 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 04, 2012
Z-MED Z-MED II
K122012 · OZT
NuMED, Inc.
Cardiovascular · 86d
Cleared Oct 03, 2012
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
K120125 · DXQ
Ge Medical Systems Information...
Cardiovascular · 260d
Cleared Oct 02, 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K122133 · MWI
Airstrip Technologies, LP
Cardiovascular · 76d
Cleared Sep 27, 2012
SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
K121504 · DYB
Togo Medikit Co., Ltd.
Cardiovascular · 129d
Cleared Sep 26, 2012
COOLRAIL LINEAR PEN MODEL MCRI
K122611 · OCL
AtriCure, Inc.
Cardiovascular · 30d
Cleared Sep 26, 2012
ELECTRONIC STETHOSCOPE
K121144 · DQD
Sharp Corporation
Cardiovascular · 163d
Cleared Sep 25, 2012
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
K121219 · DQY
Medtronic, Inc.
Cardiovascular · 155d
Cleared Sep 25, 2012
ZOLL R SERIES
K120907 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 183d
Cleared Sep 24, 2012
BLOOD PRESSURE MONITOR WITH STETHOSCOPE
K122259 · DXQ
Hangzhou Reli-On Co., Ltd.
Cardiovascular · 59d
Cleared Sep 21, 2012
OSTIAL PRO STENT POSITIONING SYSTEM
K122089 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Sep 20, 2012
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP...
K120462 · MLO
Inovise Medical, Inc.
Cardiovascular · 218d
Cleared Sep 19, 2012
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
K121917 · QEW
Penumbra, Inc.
Cardiovascular · 79d
Cleared Sep 19, 2012
MERIT HYDROPHILIC GUIDE WIRE
K120644 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 201d
Cleared Sep 17, 2012
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
K122506 · DQX
Surefire Medical, Inc.
Cardiovascular · 31d
Cleared Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
K121694 · DQO
Boston Scientific Corp
Cardiovascular · 99d
Cleared Sep 14, 2012
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE...
K100645 · DTZ
Medtronic, Inc.
Cardiovascular · 924d
Cleared Sep 13, 2012
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · MCW
Boston Scientific Corp
Cardiovascular · 87d
Cleared Sep 10, 2012
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX
K122612 · MAL
Maquet Cardiovascular, LLC
Cardiovascular · 14d
Cleared Sep 10, 2012
EARLYSENSE CENTRAL DISPLAY SYSTEM
K121885 · MSX
Earlysense, Ltd.
Cardiovascular · 74d
Cleared Sep 10, 2012
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K121372 · DXN
Andon Health Co, Ltd.
Cardiovascular · 126d
Cleared Sep 10, 2012
VISIONS PV .035 DITITAL IVUS CATHETER
K121273 · OBJ
Volcano Corporation
Cardiovascular · 136d
Cleared Sep 07, 2012
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
K122301 · DTL
Vascular Solutions Zerusa , Ltd.
Cardiovascular · 37d
Cleared Sep 07, 2012
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K113821 · DXG
Transonic Systems, Inc.
Cardiovascular · 255d
Cleared Sep 06, 2012
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
K122628 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 9d