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
3169–3192 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 15, 2016
Steth IO
K160016 · DQD
Stratoscientific, Inc.
Cardiovascular · 192d
Cleared Jul 14, 2016
Wingman 18 Crossing Catheter
K160848 · DQY
Reflow Medical, Inc.
Cardiovascular · 108d
Cleared Jul 13, 2016
ActiveCare Home
K160431 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 148d
Cleared Jul 12, 2016
ARTLINE
K160448 · DQY
Health Line International Corporation
Cardiovascular · 145d
Cleared Jul 08, 2016
TightRail Sub-C Rotating Dilator Sheath
K161333 · DRE
Spectranetics, Inc.
Cardiovascular · 57d
Cleared Jul 06, 2016
LD-Oxi system
K160956 · MWI
Ld Technology, LLC
Cardiovascular · 92d
Cleared Jul 06, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160557 · DXN
Health & Life Co., Ltd.
Cardiovascular · 128d
Cleared Jul 06, 2016
SunTech CT40 Spot-check Vital Signs Device
K160439 · DXN
Suntech Medical
Cardiovascular · 140d
Cleared Jul 05, 2016
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
K153533 · DYB
Galt Medical Corp.
Cardiovascular · 209d
Cleared Jul 01, 2016
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement...
K161531 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 29d
Cleared Jul 01, 2016
INDIGO Aspiration System
K161523 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Jul 01, 2016
PC ECG
K161302 · DPS
Edan Instruments, Inc.
Cardiovascular · 53d
Cleared Jun 28, 2016
MRI Patient Monitor TeslaDUO
K153739 · MWI
Mipm Mammendorfer Institut Fur Physik...
Cardiovascular · 183d
Cleared Jun 24, 2016
CareEvent inclusive of the CareEvent Mobile Application accessory
K161164 · MSX
Philips Medical Systems
Cardiovascular · 60d
Cleared Jun 24, 2016
Digital Blood Pressure Monitor
K153033 · DXN
Suzhou Sunspiri Co., Ltd.
Cardiovascular · 249d
Cleared Jun 23, 2016
NC Quantum Apex PTCA Dilatation Catheter
K160823 · LOX
Boston Scientific Corporation
Cardiovascular · 90d
Cleared Jun 23, 2016
Chocolate XD PTCA Balloon Catheter
K153682 · LOX
Trireme Medical, LLC
Cardiovascular · 184d
Cleared Jun 23, 2016
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology...
K153006 · NLH
Sterilmed, Inc.
Cardiovascular · 253d
Cleared Jun 22, 2016
OptiCross 18, 30 MHz Peripheral Imaging Catheter
K160514 · OBJ
Boston Scientific Corporation
Cardiovascular · 119d
Cleared Jun 22, 2016
Portable ECG Monitor
K152863 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 266d
Cleared Jun 21, 2016
Masimo Root Monitoring System and Accessories
K153225 · MWI
Masimo Corporation
Cardiovascular · 228d
Cleared Jun 21, 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Jun 20, 2016
REBOA Balloon Catheter
K160598 · MJN
NuMED, Inc.
Cardiovascular · 110d
Cleared Jun 17, 2016
CenterCross Ultra Catheter
K160681 · DQY
Roxwood Medical, Inc.
Cardiovascular · 99d