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
3193–3216 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 16, 2016
PreSep Oligon Oximetry Catheter
K160645 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 101d
Cleared Jun 15, 2016
NormaTec PCD-T and PCD-B
K161346 · JOW
NormaTec Industries, LP
Cardiovascular · 30d
Cleared Jun 14, 2016
ASAHI Corsair Armet
K161362 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Jun 14, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K161156 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Jun 13, 2016
NR Recorder
K161062 · MWJ
Norav Medical GmbH
Cardiovascular · 59d
Cleared Jun 13, 2016
Medline Singe Patient Use Blood Pressure Cuff
K161035 · DXQ
Medline Industries, Inc.
Cardiovascular · 61d
Cleared Jun 13, 2016
Arrow Quickflash Arterial Catheterization Device
K160018 · DQX
Arrow International, Inc. (Subsidiary...
Cardiovascular · 160d
Cleared Jun 13, 2016
M3290B Philips IntelliVue Information Center iX
K153702 · MHX
Philips Medical Systems
Cardiovascular · 173d
Cleared Jun 10, 2016
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K160496 · NLH
Innovative Health, LLC
Cardiovascular · 109d
Cleared Jun 09, 2016
Masimo O3 Regional Oximeter System
K160526 · MUD
Masimo Corporation
Cardiovascular · 105d
Cleared Jun 03, 2016
Halo One Thin-Walled Guiding Sheath
K161183 · DYB
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Jun 03, 2016
LifeStream Management System, LifeStream Management Suite, LifeStream Patient...
K153719 · DRG
Honeywell Hommed, LLC
Cardiovascular · 158d
Cleared Jun 01, 2016
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System,...
K160552 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 93d
Cleared Jun 01, 2016
AGE Automatic Upper Arm Blood Pressure Monitor
K153552 · DXN
Ageless Health Industrial Co., Ltd.
Cardiovascular · 173d
Cleared May 31, 2016
Cirona 6400
K161209 · JOW
Devon Medical Products
Cardiovascular · 33d
Cleared May 27, 2016
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
K151781 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 331d
Cleared May 26, 2016
Reveal LINQ
K160809 · MXD
Medtronic, Inc.
Cardiovascular · 63d
Cleared May 25, 2016
Smartdop XT6
K153762 · JOP
Koven Technology, Inc.
Cardiovascular · 147d
Cleared May 25, 2016
EMMa Electronic Monitoring Management
K153477 · DSI
Vitasystems GmbH
Cardiovascular · 175d
Cleared May 25, 2016
FLEX SCORING CATHETER
K152789 · PNO
Venturemed Group
Cardiovascular · 243d
Cleared May 24, 2016
CROSSER CTO Recanalization Catheter
K161208 · PDU
Bard Peripheral Vacular, Inc.
Cardiovascular · 26d
Cleared May 24, 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
K160533 · QEW
Penumbra, Inc.
Cardiovascular · 96d
Cleared May 20, 2016
BIB Stent Placement Catheter
K160889 · NVM
NuMED, Inc.
Cardiovascular · 50d
Cleared May 19, 2016
OptiCross X, 40 MHz Coronary Imaging Catheter
K161125 · OBJ
Boston Scientific Corporation
Cardiovascular · 28d