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
3097–3120 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 12, 2016
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
K161815 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 103d
Cleared Oct 12, 2016
Navien Intracranial Support Catheter
K161152 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 170d
Cleared Oct 07, 2016
Pantera Pro
K160985 · LOX
Biotronik, Inc.
Cardiovascular · 182d
Cleared Oct 07, 2016
EnSite Velocity Surface Electrode Kit
K160186 · DQK
St Jude Medical
Cardiovascular · 254d
Cleared Oct 06, 2016
Sapphire NC Plus
K162209 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 62d
Cleared Oct 06, 2016
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
K161584 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 120d
Cleared Oct 06, 2016
MR Syringe Dual Pack for Solaris Injectors
K161471 · DXT
Coeur, Inc.
Cardiovascular · 132d
Cleared Sep 30, 2016
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K161464 · NLH
Innovative Health, LLC
Cardiovascular · 127d
Cleared Sep 30, 2016
Electronic Stethoscope DS301
K160023 · DQD
Imediplus, Inc.
Cardiovascular · 268d
Cleared Sep 30, 2016
eCareManager 4.0.1
K153156 · MSX
Visicu, Inc.
Cardiovascular · 333d
Cleared Sep 26, 2016
Penumbra Aspiration System
K161506 · QEW
Penumbra, Inc.
Cardiovascular · 117d
Cleared Sep 26, 2016
Endophys Blood Pressure Monitor
K160945 · DSK
Endophys Holdings, LLC
Cardiovascular · 174d
Cleared Sep 22, 2016
TrailBlazer Angled Support Catheter
K162384 · DQY
Medtronic Vascular, Inc.(Formerly Ev3...
Cardiovascular · 28d
Cleared Sep 22, 2016
BIB Stent Placement Catheter
K161451 · NVM
NuMED, Inc.
Cardiovascular · 119d
Cleared Sep 21, 2016
Surefire Guiding Catheter
K162359 · DQY
Surefire Medical, Inc.
Cardiovascular · 29d
Cleared Sep 21, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K162338 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Sep 21, 2016
Affinity NT Oxygenator with Cortiva BioActive Surface
K162016 · DTZ
Medtronic, Inc.
Cardiovascular · 62d
Cleared Sep 20, 2016
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure...
K161887 · DQX
Volcano Corporation
Cardiovascular · 71d
Cleared Sep 20, 2016
Hansen Medical Magellan Robotic Catheter 9Fr
K160919 · DRA
Hansen Medical, Inc.
Cardiovascular · 169d
Cleared Sep 19, 2016
Super Distal Access (SDA)
K161262 · DQY
Inneuroco, Inc.
Cardiovascular · 137d
Cleared Sep 19, 2016
AirStrip RPM
K160862 · MSX
Airstrip Technologies, Inc.
Cardiovascular · 174d
Cleared Sep 16, 2016
Sentry WEB SmartInterp
K153654 · DQK
Carefusion Germany 234 GmbH
Cardiovascular · 270d
Cleared Sep 15, 2016
CARESCAPE Central Station V2
K162012 · DXJ
Ge Healthcare
Cardiovascular · 56d
Cleared Sep 14, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and...
K161384 · PPN
Shockwave Medical, Inc.
Cardiovascular · 118d