Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
1321–1344 of 18,182
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