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
5473–5496 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 02, 2010
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL...
K101667 · DQK
St Jude Medical
Cardiovascular · 18d
Cleared Jul 02, 2010
CHEETAH NICOM SYSTEM
K101487 · DXG
Cheetah Medical, Inc.
Cardiovascular · 35d
Cleared Jul 02, 2010
MD VISION SYSTEM
K101474 · DXJ
Perkins Healthcare Technologies
Cardiovascular · 35d
Cleared Jul 02, 2010
ELI 250 ELECTROCARDIOGRAPH
K101403 · DPS
Mortara Instrument, Inc.
Cardiovascular · 44d
Cleared Jul 02, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
K100620 · DXN
Harvard Medical Devices , Ltd.
Cardiovascular · 120d
Cleared Jul 01, 2010
IP-SET
K101685 · DRX
Integral Process Sas
Cardiovascular · 15d
Cleared Jul 01, 2010
THERMODILUTION CATHETER
K101669 · DQO
Biosensors Intl. Pte. , Ltd.
Cardiovascular · 17d
Cleared Jul 01, 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE...
K101512 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 30d
Cleared Jul 01, 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
K093877 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 197d
Cleared Jun 30, 2010
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
K093993 · OGZ
Infraredx, Inc.
Cardiovascular · 188d
Cleared Jun 29, 2010
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
K101178 · DRG
Intel Corp.
Cardiovascular · 63d
Cleared Jun 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965
K100940 · DXN
Andon Health Co, Ltd.
Cardiovascular · 85d
Cleared Jun 25, 2010
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
K101639 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 15d
Cleared Jun 25, 2010
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K101431 · DTK
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Jun 23, 2010
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING,...
K101116 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 63d
Cleared Jun 22, 2010
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ...
K101345 · DRF
Biosense Webster, Inc.
Cardiovascular · 40d
Cleared Jun 22, 2010
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
K101138 · OBJ
Biosense Webster, Inc.
Cardiovascular · 61d
Cleared Jun 22, 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · KFM
Medtronic, Inc.
Cardiovascular · 109d
Cleared Jun 18, 2010
INTELLIVUE PATIENT MONITOR
K101449 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 25d
Cleared Jun 18, 2010
ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
K101115 · DPS
Mortara Instrument, Inc.
Cardiovascular · 58d
Cleared Jun 18, 2010
MULTIFUNCTIONAL LINEAR PEN
K100501 · OCL
AtriCure, Inc.
Cardiovascular · 116d
Cleared Jun 18, 2010
CARTO XP EP NAVIGATION SYSTEM, VERSION 10
K093566 · DQK
Biosense Webster, Inc.
Cardiovascular · 212d
Cleared Jun 18, 2010
LASSO NAV CATHETER
K093376 · DRF
Biosense Webster, Inc.
Cardiovascular · 232d
Cleared Jun 18, 2010
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE...
K091786 · DXG
Pulsion Medical Systems AG
Cardiovascular · 366d