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
4993–5016 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 06, 2011
XL EXTRACTION CATHETER
K112571 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Oct 06, 2011
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
K103643 · DRG
Ascot Technologies, Inc.
Cardiovascular · 297d
Cleared Oct 05, 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
K112007 · DQK
Biosense Webster, Inc.
Cardiovascular · 83d
Cleared Oct 04, 2011
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL...
K111905 · DXJ
Philips Medizinsysteme Boeblingen...
Cardiovascular · 91d
Cleared Oct 04, 2011
CARDIOMED
K103651 · LDD
Cardio Medical Products, Inc.
Cardiovascular · 294d
Cleared Oct 03, 2011
ARMADA 35/35LL PTA CATHETER
K111899 · LIT
Abbott Vascular
Cardiovascular · 90d
Cleared Oct 03, 2011
MOBICATH TRANSSEPTAL NEEDLE
K111644 · DRC
Great Batch Medical
Cardiovascular · 112d
Cleared Oct 03, 2011
PINNACLE PRECISION ACCESS SYSTEM
K111606 · DYB
Terumo Medical Corp.
Cardiovascular · 116d
Cleared Sep 30, 2011
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K112320 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Sep 30, 2011
DYNAMIC ECG SYSTEM MODEL TLC5000
K101273 · MLO
Contec Medical System Co., Ltd.
Cardiovascular · 512d
Cleared Sep 29, 2011
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
K112525 · DTM
Parexel International
Cardiovascular · 29d
Cleared Sep 29, 2011
AGILLS PF DELIVERY SYSTEM
K111943 · DYB
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 83d
Cleared Sep 29, 2011
SCEPTER C OCCLUSION BALLOON CATHETER
K110741 · MJN
MicroVention, Inc.
Cardiovascular · 197d
Cleared Sep 27, 2011
RADIAL ARTERY COMPRESSION TOURNIQUET
K111837 · DXC
Lepu Medical Technology (Beijing)...
Cardiovascular · 90d
Cleared Sep 26, 2011
SELECTRA SLITTER TOOL
K112482 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2011
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K112232 · NLH
Stryker Sustainability Solutions
Cardiovascular · 53d
Cleared Sep 26, 2011
SELECTRA ACCESSORY KIT
K111839 · DQY
Biotronik, Inc.
Cardiovascular · 89d
Cleared Sep 23, 2011
ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
K110913 · OCL
Endoscopic Technologies, Inc. D/B/A...
Cardiovascular · 175d
Cleared Sep 23, 2011
RHYTHMVIEW (TM)
K110878 · DQK
Topera, Inc.
Cardiovascular · 177d
Cleared Sep 22, 2011
RADIFORCE LARGE MONITOR SYSTEM
K112645 · DXJ
Eizo GmbH
Cardiovascular · 10d
Cleared Sep 22, 2011
PULSIOFLEX
K112448 · DXG
Pulsion Medical Systems, Inc.
Cardiovascular · 28d
Cleared Sep 22, 2011
DIGITAL ELECTROCARDIOGRAPH
K112431 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 30d
Cleared Sep 20, 2011
SORIN CENTRIFUGAL PUMP 5 (CP5)
K112225 · DWA
Sorin Group Deutschland GmbH
Cardiovascular · 48d
Cleared Sep 20, 2011
TANDEMHEART PUMP
K110493 · KFM
Cardiacassist, Inc.
Cardiovascular · 210d