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
6217–6240 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 01, 2008
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K082045 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 14d
Cleared Aug 01, 2008
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523 · NFA
Medtronic, Inc.
Cardiovascular · 231d
Cleared Jul 31, 2008
SKYLINE 55
K081552 · MWI
Larsen & Toubro Limited
Cardiovascular · 58d
Cleared Jul 31, 2008
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
K081444 · DSI
Braemar, Inc.
Cardiovascular · 70d
Cleared Jul 31, 2008
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080326 · DXN
Andon Health Co, Ltd.
Cardiovascular · 176d
Cleared Jul 31, 2008
STATMAP, MODEL 7200
K072109 · DXN
Ramsey Medical, Inc.
Cardiovascular · 365d
Cleared Jul 30, 2008
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
K080832 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 127d
Cleared Jul 30, 2008
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J)...
K080668 · DTK
C.R. Bard, Inc.
Cardiovascular · 142d
Cleared Jul 29, 2008
LIFEPAK 20E
K073089 · MKJ
Physio-Control, Inc.
Cardiovascular · 271d
Cleared Jul 28, 2008
T-STAT 303 ISCHEMIA MONITORING SYSTEM
K081233 · MUD
Spectros Corporation
Cardiovascular · 88d
Cleared Jul 28, 2008
VALVULOTOME BY KOVEN
K080178 · MGZ
Koven Technology, Inc.
Cardiovascular · 186d
Cleared Jul 25, 2008
MICROSHEATH LP AND LP-AT
K080849 · DQY
Flowcardia, Inc.
Cardiovascular · 121d
Cleared Jul 25, 2008
EPICOR ABLATION SYSTEM
K080292 · OCL
St Jude Medical
Cardiovascular · 172d
Cleared Jul 22, 2008
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
K081776 · DXG
Omega Critical Care Limited
Cardiovascular · 29d
Cleared Jul 18, 2008
MODIFIED HD GUIDE CATHETER
K080583 · DQY
Concentric Medical, Inc.
Cardiovascular · 137d
Cleared Jul 17, 2008
PATHWAY PV ATHERECTOMY SYSTEM
K081328 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 66d
Cleared Jul 17, 2008
VISENSIA
K081140 · MHX
Obs Medical
Cardiovascular · 86d
Cleared Jul 15, 2008
MAC 1600 ECG ANALYSIS SYSTEM
K081437 · DPS
Ge Medical Systems Information...
Cardiovascular · 54d
Cleared Jul 14, 2008
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
K080982 · LIT
Boston Scientific Corp
Cardiovascular · 98d
Cleared Jul 11, 2008
CARDIOSEN'C
K080047 · DXH
Shl Telemedicine International , Ltd.
Cardiovascular · 185d
Cleared Jul 10, 2008
NUCLEUS-X, MODEL 230X
K081680 · DQY
NuMED, Inc.
Cardiovascular · 23d
Cleared Jul 09, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K081329 · NLH
Ascent Healthcare Solutions
Cardiovascular · 58d
Cleared Jul 03, 2008
VASCON ROAMER MICROCATHETER
K053310 · KRA
Vascon, LLC
Cardiovascular · 948d
Cleared Jul 02, 2008
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080319 · DXN
Andon Health Co, Ltd.
Cardiovascular · 147d