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
3313–3336 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 05, 2016
Vital Signs Patch System
K151835 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 214d
Cleared Feb 04, 2016
DyeVert Contrast Modulation System
K153141 · DXT
Osprey Medical, Inc.
Cardiovascular · 97d
Cleared Feb 04, 2016
CorMatrix Tyke
K152127 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 188d
Cleared Feb 02, 2016
iHealth Track Blood Pressure Monitor
K160014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Feb 01, 2016
Hansen Medical Magellan Robotic Catheter eKit
K153304 · DRA
Hansen Medical, Inc.
Cardiovascular · 77d
Cleared Jan 30, 2016
ROSC-U Mini Chest Compressor (RMCC)
K153628 · DRM
Resuscitation International, LLC
Cardiovascular · 43d
Cleared Jan 27, 2016
8F FlowGate2 Balloon Guide Catheter
K153729 · DQY
Concentric Medical
Cardiovascular · 30d
Cleared Jan 27, 2016
Holter System
K151787 · DQK
Edan Instruments, Inc.
Cardiovascular · 210d
Cleared Jan 26, 2016
CenterCross Ultra Catheter
K152456 · DQY
Roxwood Medical, Inc.
Cardiovascular · 151d
Cleared Jan 26, 2016
PATIENT MONITORS VARIOUS MODELS
K151812 · MHX
Philips Medical Systems
Cardiovascular · 208d
Cleared Jan 22, 2016
Crosperio RX PTA Balloon Dilatation Catheter
K152887 · LIT
KANEKA Corporation
Cardiovascular · 114d
Cleared Jan 22, 2016
Crosstella RX Balloon Dilatation Catheter
K152873 · LIT
KANEKA Corporation
Cardiovascular · 114d
Cleared Jan 22, 2016
PW Guidewires
K152497 · DQX
Tatara Vascular, LLC
Cardiovascular · 143d
Cleared Jan 22, 2016
ASAHI Caravel
K152447 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 148d
Cleared Jan 22, 2016
Livewire Electrophysiology Catheter
K151617 · NLH
Surgical Instrument Service and...
Cardiovascular · 221d
Cleared Jan 22, 2016
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III...
K151048 · IZQ
Bracco Injeneering
Cardiovascular · 277d
Cleared Jan 21, 2016
Pruitt F3-S Polyurethane Carotid Shunt
K152833 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 114d
Cleared Jan 20, 2016
basixTOUCH40 Inflation Syringe
K153672 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 19, 2016
Flo Trac sensor, Volume View sensor
K152980 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared Jan 19, 2016
True Flow Valvuloplasty Perfusion Catheter
K152613 · OZT
C.R. Bard, Inc.
Cardiovascular · 127d
Cleared Jan 15, 2016
Medtronic Bio-Medicus Adult Cannula Kit
K153598 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2016
Esophageal Cooling Device
K152450 · PLA
Advanced Cooling Therapy, LLC
Cardiovascular · 140d
Cleared Jan 15, 2016
ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
K151269 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 247d
Cleared Jan 14, 2016
OptiOne Single-Head Contrast Delivery System with Pedestal
K152361 · IZQ
Liebel-Flarsheim Company, LLC
Cardiovascular · 147d