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
7705–7728 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 11, 2004
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K040453 · DRM
Revivant Corp.
Cardiovascular · 17d
Cleared Mar 10, 2004
RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
K034046 · DQD
Rnk Products
Cardiovascular · 72d
Cleared Mar 10, 2004
HEALTH BUDDY WITH BUDDYLINK
K040086 · DXN
Health Hero Network, Inc.
Cardiovascular · 54d
Cleared Mar 09, 2004
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER
K033807 · DRQ
Draeger Medical Systems, Inc.
Cardiovascular · 92d
Cleared Mar 09, 2004
STEERABLE STYLET
K040001 · DRB
Synovis Surgical Innovations
Cardiovascular · 67d
Cleared Mar 05, 2004
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
K033410 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 130d
Cleared Mar 03, 2004
RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
K031903 · DTZ
Guidant Corporation
Cardiovascular · 257d
Cleared Mar 03, 2004
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · DRT
Shenzhen Mindray Bio-Medical...
Cardiovascular · 181d
Cleared Mar 03, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K040037 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d
Cleared Mar 03, 2004
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
K040210 · DTZ
Terumo Corp.
Cardiovascular · 33d
Cleared Mar 03, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A...
K040357 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 19d
Cleared Mar 02, 2004
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
K033881 · DXT
Medrad, Inc.
Cardiovascular · 78d
Cleared Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · DQX
Ev3, Inc.
Cardiovascular · 19d
Cleared Mar 01, 2004
VITAL SIGNS MONITOR, PROPAQ LT
K033378 · MWI
Welch Allyn Protocol, Inc.
Cardiovascular · 131d
Cleared Mar 01, 2004
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
K033617 · DRN
Vasomedical, Inc.
Cardiovascular · 104d
Cleared Mar 01, 2004
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 54d
Cleared Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · DQX
Arrow Intl., Inc.
Cardiovascular · 41d
Cleared Mar 01, 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 21d
Cleared Feb 27, 2004
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K032421 · MKJ
Ambu, Inc.
Cardiovascular · 206d
Cleared Feb 27, 2004
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
K033771 · MKJ
Bio-Detek, Inc.
Cardiovascular · 86d
Cleared Feb 27, 2004
CENTRAL STATION, VERSION 3.3H
K040032 · DXN
Hommed, LLC
Cardiovascular · 50d
Cleared Feb 27, 2004
EP-4 CLINICAL STIMULATOR
K040207 · JOQ
Ep Medsystems
Cardiovascular · 28d
Cleared Feb 26, 2004
ENVOY PATIENT MONITOR
K030722 · MHX
Mennen Medical, Inc.
Cardiovascular · 356d
Cleared Feb 26, 2004
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 31d