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
3001–3024 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 17, 2017
Chameleon PTA Balloon Catheter
K163231 · LIT
Av Medical Technologies, Ltd.
Cardiovascular · 61d
Cleared Jan 12, 2017
Ostial Sprit Cannulae
K162500 · DWF
Spyder Medical
Cardiovascular · 127d
Cleared Jan 11, 2017
R2P Metacross RX
K163479 · LIT
KANEKA Corporation
Cardiovascular · 30d
Cleared Jan 11, 2017
Mortara Surveyor Patient Monitor
K161517 · MHX
Mortara Instrument, Inc.
Cardiovascular · 223d
Cleared Jan 06, 2017
Spectre guidewire
K163444 · DQX
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Jan 06, 2017
NAMIC ClearaCIL Contrast Injection Lines
K163141 · DQO
AngioDynamics, Inc.
Cardiovascular · 58d
Cleared Jan 06, 2017
Trapper Exchange Device
K162253 · DQY
Creganna Medical Aslo Business AS...
Cardiovascular · 149d
Cleared Jan 06, 2017
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
K162181 · DRE
Cardiacassist, Inc.
Cardiovascular · 155d
Cleared Jan 05, 2017
Sapphire II PRO
K163114 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 59d
Cleared Jan 05, 2017
YOGA Microcatheter
K162563 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 113d
Cleared Jan 05, 2017
Turbo-Power (2.0mm) Laser Atherectomy Catheters
K162561 · MCW
Spectranetics, Inc.
Cardiovascular · 113d
Cleared Jan 04, 2017
Truscope Ultra Patient Monitor
K162234 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 148d
Cleared Jan 03, 2017
Isolator Multifunctional Linear Pen
K163408 · OCL
AtriCure, Inc.
Cardiovascular · 29d
Cleared Dec 23, 2016
Reprocessed Kendall SCD Express Foot Cuff
K163055 · JOW
Covidien
Cardiovascular · 52d
Cleared Dec 23, 2016
AMPLATZER TorqVue 45x45 Delivery Sheath
K163000 · DQY
Aga Medical COrporation (Wholly Owned...
Cardiovascular · 56d
Cleared Dec 22, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter
K163306 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared Dec 22, 2016
Patient Monitor
K160981 · MHX
Edan Instruments, Inc.
Cardiovascular · 259d
Cleared Dec 21, 2016
Pantheris Catheter (8F)
K163264 · MCW
Avinger, Inc.
Cardiovascular · 30d
Cleared Dec 21, 2016
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · NLH
Innovative Health, LLC
Cardiovascular · 133d
Cleared Dec 21, 2016
TelePatch Cardiac Monitor
K161916 · DRG
Medicomp, Inc.
Cardiovascular · 162d
Cleared Dec 21, 2016
Ox-Imager CS
K153426 · MUD
Modulated Imaging, Inc.
Cardiovascular · 392d
Not Cleared Dec 21, 2016
CipherOx CRI Tablet
DEN160020 · PPW
Flashback Technologies, Inc.
Cardiovascular · 211d
Cleared Dec 16, 2016
LC Bead LUMI
K162373 · KRD
Biocompatibles UK Limited
Cardiovascular · 114d
Cleared Dec 16, 2016
HyperView Hyperspectral Tissue Oxygenation Measurement System
K161237 · MUD
Hypermed Imaging, Inc.
Cardiovascular · 228d