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
1249–1272 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 30, 2022
INDEX BPM
K221486 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 99d
Cleared Aug 30, 2022
Arrow Stiffening Stylet
K220280 · DRB
Arrow International, LLC (A...
Cardiovascular · 210d
Cleared Aug 29, 2022
Blood Pressure Monitor
K220676 · DXN
Guangdong Transtek Medical...
Cardiovascular · 174d
Cleared Aug 26, 2022
Upper Arm Blood Pressure Monitor
K221212 · DXN
Shenzhen Yolanda Technology Co., Ltd.
Cardiovascular · 121d
Cleared Aug 25, 2022
LINQ II Insertable Cardiac Monitor
K221962 · MXD
Medtronic, Inc.
Cardiovascular · 51d
Cleared Aug 24, 2022
TightRail Guardian Motorized Dilator Sheath
K212784 · DRE
Spectranetics, Inc.
Cardiovascular · 357d
Cleared Aug 22, 2022
SABER .014 PTA Dilatation Catheter
K221832 · LIT
Cordis US Corp
Cardiovascular · 60d
Cleared Aug 22, 2022
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy...
K221528 · DXF
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Aug 19, 2022
Stent Positioning Assistance System (SPAS)
K221917 · DQX
Seven Sons , Ltd.
Cardiovascular · 50d
Cleared Aug 18, 2022
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen...
K221353 · DWF
Qura S.R.L
Cardiovascular · 100d
Cleared Aug 18, 2022
EnSite X EP System
K221213 · DQK
Abbott
Cardiovascular · 113d
Cleared Aug 18, 2022
GuideLiner Coast, 5.5F (5270)
K220647 · DQY
Vascular Solutions, LLC
Cardiovascular · 164d
Cleared Aug 17, 2022
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
K221112 · DQK
Biosense Webster, Inc.
Cardiovascular · 124d
Cleared Aug 16, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K221852 · PPN
Shockwave Medical, Inc.
Cardiovascular · 50d
Cleared Aug 15, 2022
HeRO Graft
K213845 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 249d
Cleared Aug 11, 2022
Patient Monitor: RespArray
K220308 · MHX
Edan Instruments, Inc.
Cardiovascular · 190d
Cleared Aug 10, 2022
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
K221879 · MHX
Caf Medical Solutions, Inc.
Cardiovascular · 43d
Cleared Aug 09, 2022
LimFlow V-Ceiver
K222083 · MMX
LimFlow, Inc.
Cardiovascular · 25d
Cleared Aug 06, 2022
Reprocesses Umbilical Cable
K221854 · NLH
Innovative Health, LLC
Cardiovascular · 40d
Cleared Aug 04, 2022
exGraft, exGraft Carbon
K221628 · DSY
Peca Labs
Cardiovascular · 59d
Cleared Aug 04, 2022
Mini-ClotTriever Thrombectomy System
K220887 · QEW
Inari Medical
Cardiovascular · 129d
Cleared Aug 02, 2022
QOCA Portable ECG Monitoring Device
K210179 · DSH
Quanta Computer, Inc.
Cardiovascular · 557d
Cleared Aug 01, 2022
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
K221616 · MHX
Caf Medical Solutions, Inc.
Cardiovascular · 59d
Cleared Jul 29, 2022
Catapult Guide Sheath
K221914 · DYB
Contract Medical International, GmbH
Cardiovascular · 29d