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
6817–6840 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 20, 2006
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT...
K062283 · MHX
Philips Medical Systems North...
Cardiovascular · 44d
Cleared Sep 20, 2006
RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
K062275 · QEZ
Kerberos Proximal Solutions, Inc.
Cardiovascular · 44d
Cleared Sep 20, 2006
FETCH ASPIRATION CATHETER
K062172 · QEZ
Possis Medical, Inc.
Cardiovascular · 51d
Cleared Sep 20, 2006
THERMOSUIT SYSTEM
K061023 · NZE
Life Recovery Systems Hd, LLC
Cardiovascular · 160d
Cleared Sep 19, 2006
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
K062278 · MSX
Spacelabs Medical, Inc.
Cardiovascular · 43d
Cleared Sep 19, 2006
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
K061573 · DRS
Hospira, Inc.
Cardiovascular · 104d
Cleared Sep 15, 2006
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
K061780 · DXH
Rozinn Electronics, Inc.
Cardiovascular · 81d
Cleared Sep 15, 2006
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · DQK
Ge Healthcare
Cardiovascular · 87d
Cleared Sep 15, 2006
FUSION
K061557 · DXN
Medwave, Inc.
Cardiovascular · 102d
Cleared Sep 15, 2006
MEDIC4ALL TELEMEDICINE SYSTEM VMS-01
K061502 · DRG
Medic4all (Israel) , Ltd.
Cardiovascular · 107d
Cleared Sep 14, 2006
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
K061932 · MSX
Cardiopulmonary Corp.
Cardiovascular · 69d
Cleared Sep 13, 2006
SPECTRUM M2 MONITOR
K062468 · DRY
Spectrum Medical, Llp
Cardiovascular · 20d
Cleared Sep 13, 2006
PROXIS SYSTEM, MODEL EPS101
K060651 · NFA
St Jude Medical
Cardiovascular · 184d
Cleared Sep 11, 2006
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
K061471 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 108d
Cleared Sep 08, 2006
5F SHERPA ACTIVE NX GUIDE CATHETER
K062420 · DQY
Medtronic Vascular
Cardiovascular · 21d
Cleared Sep 07, 2006
PROXIS SYSTEM
K052523 · NFA
Velocimed, Inc.
Cardiovascular · 358d
Cleared Sep 06, 2006
PHILIPS MP5 INTELLIVUE PATIENT MONITOR
K062392 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 21d
Cleared Sep 05, 2006
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
K061960 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 56d
Cleared Sep 05, 2006
MEDTRONIC EXPORT XT CATHETER
K061958 · QEZ
Medtronic Vascular
Cardiovascular · 56d
Cleared Sep 01, 2006
BOOMERANG WIRE
K061075 · DXC
Cardiva Medical, Inc.
Cardiovascular · 137d
Cleared Aug 31, 2006
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K061045 · NLH
Alliance Medical Corp.
Cardiovascular · 139d
Cleared Aug 25, 2006
PREMIER 11 HOLTER
K062088 · MLO
Diagnostic Monitoring Software
Cardiovascular · 32d
Cleared Aug 25, 2006
TELAHEART DIGITAL RECORDER
K061293 · MWJ
North East Monitoring, Inc.
Cardiovascular · 108d
Cleared Aug 24, 2006
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
K062381 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 9d