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
3145–3168 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 10, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160565 · DXN
Andon Health Co, Ltd.
Cardiovascular · 163d
Cleared Aug 09, 2016
Quantitative Electrocardiographic Detector (QED 2000)
K152135 · DPS
Acme Portable Machines, Inc.
Cardiovascular · 375d
Cleared Aug 08, 2016
Apollo Balloon Dilatation Catheter
K153742 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 224d
Cleared Aug 07, 2016
Steerable Guide Catheter
K161985 · DRA
Abbott Vascular
Cardiovascular · 19d
Cleared Aug 05, 2016
EP-TRACER System
K161245 · DQK
Cardio Tek, BV
Cardiovascular · 94d
Cleared Aug 04, 2016
SIDEKICK and USHER Support Catheters
K161986 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 16d
Cleared Aug 04, 2016
Surveyor S4 Mobile Monitor
K160685 · MHX
Mortara Instrument, Inc.
Cardiovascular · 146d
Cleared Aug 04, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160563 · DXN
Andon Health Co, Ltd.
Cardiovascular · 157d
Cleared Aug 03, 2016
DyeVert NG Contrast Modulation System
K161505 · DXT
Osprey Medical, Inc.
Cardiovascular · 63d
Cleared Aug 03, 2016
Hilal Embolization MicroCoils
K160219 · KRD
Cook Incorporated
Cardiovascular · 187d
Cleared Jul 30, 2016
Pirouette 035
K161427 · LIT
Arravasc Limited
Cardiovascular · 68d
Cleared Jul 30, 2016
Mozec NC-Rx PTCA Baloon Dilatation Catheter
K160961 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 116d
Cleared Jul 29, 2016
CrossCath Support Catheter
K161801 · KRA
Cook Incorporated
Cardiovascular · 29d
Cleared Jul 29, 2016
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
K160256 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 179d
Cleared Jul 29, 2016
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 192d
Cleared Jul 28, 2016
Angel Catheter
K160747 · PNS
Bio2 Medical, Inc.
Cardiovascular · 132d
Not Cleared Jul 27, 2016
Permaseal
DEN150029 · PNQ
Micro Interventional Devices,Inc.
Cardiovascular · 401d
Cleared Jul 22, 2016
Gianturco-Roehm Bird’s Nest Vena Cava Filter
K161218 · DTK
Cook Incorporated
Cardiovascular · 84d
Cleared Jul 22, 2016
Braemar Telemetry Patch System
K153473 · DSI
Braemar Manufacturing, LLC
Cardiovascular · 233d
Cleared Jul 22, 2016
Sheath Introducer
K150932 · DRE
Bioteque Corp.
Cardiovascular · 473d
Cleared Jul 21, 2016
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
K152913 · DYB
Creganna Medical Aslo Business AS...
Cardiovascular · 293d
Cleared Jul 19, 2016
ABPM 7100, Hypertension Management Software
K153557 · DXN
I.E.M. GmbH
Cardiovascular · 218d
Cleared Jul 15, 2016
FlexSeal Introducer Sheath with Hydrophilic Coating
K161659 · DYB
Libramedical, Inc.
Cardiovascular · 29d
Cleared Jul 15, 2016
myPatch-s
K160704 · DSH
Dms-Service, LLC
Cardiovascular · 123d