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
4177–4200 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 17, 2013
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942 · DXQ
Legacy Medical, Inc.
Cardiovascular · 196d
Cleared Oct 17, 2013
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K130719 · OGZ
Infraredx, Inc.
Cardiovascular · 213d
Cleared Oct 17, 2013
RESPIGUIDE DELIVERY SYSTEM
K130378 · DQY
Respicardia
Cardiovascular · 245d
Cleared Oct 16, 2013
BRAEMAR CARDIOKEY HOLTER RECORDER
K130294 · MWJ
Braemar Manufacturing, LLC
Cardiovascular · 252d
Cleared Oct 11, 2013
PCP-USB STETHOSCOPE
K132560 · DQD
Rnk Products, Inc.
Cardiovascular · 57d
Cleared Oct 11, 2013
PPA/BT-RB STETHOSCOPE
K132405 · DQD
Rnk Products, Inc.
Cardiovascular · 70d
Cleared Oct 11, 2013
MODIFIED CONCENTRIC MICROCATHETER
K131437 · DQO
Concentric Medical, Inc.
Cardiovascular · 144d
Cleared Oct 11, 2013
REVERSE MEDICAL MICROCATHETER
K130858 · DQY
Reverse Medical Corporation
Cardiovascular · 197d
Cleared Oct 11, 2013
AUDICOR CPAM WITH SDB (SINGLE SENSOR)
K130660 · MLO
Inovise Medical, Inc.
Cardiovascular · 213d
Cleared Oct 10, 2013
DELTEX MEDICAL CARDIOQ-EDM+
K132139 · DPW
Deltex Medical Limited
Cardiovascular · 91d
Cleared Oct 08, 2013
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
K132829 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 29d
Cleared Oct 07, 2013
HEM-6221
K131749 · DXN
Omron Healthcare, Inc.
Cardiovascular · 115d
Cleared Oct 07, 2013
VISI MOBILE MONITORING SYSTEM
K130709 · MWI
Sotera Wireless, Inc.
Cardiovascular · 206d
Cleared Oct 04, 2013
VITAHEAT PATIENT WARMING SYSTEM
K132454 · DWJ
Vitaheat Medical, LLC
Cardiovascular · 59d
Cleared Oct 03, 2013
EMBOZENE MICROSPHERES
K132675 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 36d
Cleared Oct 03, 2013
MODIFIED FLOWGATE BALLOON GUIDE CATHETER
K131492 · DQY
Concentric Medical, Inc.
Cardiovascular · 133d
Cleared Oct 03, 2013
OCCLUSION PERFUSION CATHETER
K130525 · DQY
Advanced Catheter Therapies, Inc.
Cardiovascular · 217d
Cleared Oct 01, 2013
PATIENT MONITOR
K123711 · MWI
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 301d
Cleared Sep 27, 2013
NMI COAXIAL MICROINTRODUCER SET
K132713 · DRE
Navilyst Medical, Inc.
Cardiovascular · 28d
Cleared Sep 27, 2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
K132659 · DQY
Volcano Corporation
Cardiovascular · 32d
Cleared Sep 27, 2013
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · DXX
Hansen Medical, Inc.
Cardiovascular · 59d
Cleared Sep 27, 2013
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · DYB
Medtronic, Inc.
Cardiovascular · 88d
Cleared Sep 27, 2013
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
K131860 · JOP
Us Vascular, LLC
Cardiovascular · 95d
Cleared Sep 27, 2013
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
K131618 · DWB
Terumo Cardiovascular Systems...
Cardiovascular · 116d