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
5545–5568 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 04, 2010
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
K100306 · JOW
Covidien
Cardiovascular · 90d
Cleared Apr 30, 2010
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50,...
K100939 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 25d
Cleared Apr 30, 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
K100930 · DQX
Volcano Corporation
Cardiovascular · 25d
Cleared Apr 30, 2010
ADMIRAL XTREME PTA BALLOON DILATATION CATHETER
K100921 · LIT
Invatec S.P.A.
Cardiovascular · 28d
Cleared Apr 30, 2010
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
K100915 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 29d
Cleared Apr 30, 2010
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING,...
K100278 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 88d
Cleared Apr 30, 2010
VSI TORQUE DEVICE
K100093 · DQX
Vascular Solutions, Inc.
Cardiovascular · 107d
Cleared Apr 29, 2010
ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL...
K100266 · MWJ
Camntech, Ltd.
Cardiovascular · 90d
Cleared Apr 29, 2010
VITAL SYNC MODEL 5000 SERIES
K093422 · MWI
Somanetics Corp.
Cardiovascular · 177d
Cleared Apr 29, 2010
STELLAR 300
K093017 · MWI
Larsen & Toubro Limited
Cardiovascular · 212d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
St Jude Medical
Cardiovascular · 47d
Cleared Apr 28, 2010
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R
K100319 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 83d
Cleared Apr 23, 2010
12 LEAD GLOVE
K100315 · DRX
I Needmd, Inc.
Cardiovascular · 78d
Cleared Apr 22, 2010
ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX
K093977 · DQY
Chestnut Medical Technologies, Inc.
Cardiovascular · 119d
Cleared Apr 21, 2010
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
K100789 · DRA
Evalve, Inc.
Cardiovascular · 30d
Cleared Apr 21, 2010
GTX 12 GIDEWIRE
K100470 · DQX
Medtronic, Inc.
Cardiovascular · 62d
Cleared Apr 20, 2010
VITAPHONE. MODEL 100 BT
K100383 · DXH
Vitasystems GmbH
Cardiovascular · 63d
Cleared Apr 20, 2010
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
K100155 · DSI
Biomedical Systems Corp.
Cardiovascular · 90d
Cleared Apr 20, 2010
CLEARWAY OTW MODEL 85912
K093431 · DQY
Atrium Medical Corp.
Cardiovascular · 167d
Cleared Apr 16, 2010
GDS-DC12
K100135 · DQY
Guided Delivery Systems
Cardiovascular · 87d
Cleared Apr 16, 2010
ELI 230 ELECTROCARDIOGRAPH
K100127 · DPS
Mortara Instrument, Inc.
Cardiovascular · 87d
Cleared Apr 15, 2010
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
K100745 · DRT
Hoana Medical, Inc.
Cardiovascular · 30d
Cleared Apr 15, 2010
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
K100394 · MWI
Shanghai 3f Electronics Co, Ltd.
Cardiovascular · 58d
Cleared Apr 14, 2010
CAMBRIDGE HEART OEM
K100362 · DQK
Cambridge Heart, Inc.
Cardiovascular · 61d