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
769–792 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 12, 2024
SOUNDSTAR™ CRYSTAL Ultrasound Catheter
K240050 · OBJ
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Jun 12, 2024
MEDIBLU ECG SYSTEM
K233266 · DPS
Mediblu Medical, LLC
Cardiovascular · 257d
Cleared Jun 11, 2024
JADE PLUS PTA Balloon Dilatation Catheter
K241025 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 57d
Not Cleared Jun 11, 2024
Mi-CHORD System
DEN230069 · SBK
Lsi Solutions, Inc.
Cardiovascular · 256d
Cleared Jun 10, 2024
Indigo® Lightning Flash Aspiration System – Select +™ Catheter
K241399 · QEW
Penumbra, Inc.
Cardiovascular · 25d
Cleared Jun 07, 2024
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
K240972 · NLH
Surgical Instrument Service and...
Cardiovascular · 59d
Cleared Jun 07, 2024
Blood Pressure Monitor (BBZ32-AA01)
K240832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 73d
Cleared Jun 07, 2024
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K233825 · NLH
Innovative Health
Cardiovascular · 189d
Cleared Jun 07, 2024
Electrocardiograph, model: ECG301
K232816 · DPS
Shenzhen LE Medical Technology Co., Ltd.
Cardiovascular · 268d
Cleared Jun 07, 2024
FibriCheck
K232804 · QME
Qompium NV
Cardiovascular · 269d
Cleared Jun 07, 2024
Impala
K232035 · DPS
AliveCor, Inc.
Cardiovascular · 336d
Cleared Jun 07, 2024
Corvair
K231010 · MHX
AliveCor, Inc.
Cardiovascular · 427d
Cleared Jun 06, 2024
Swan-Ganz catheter
K233824 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 188d
Cleared Jun 03, 2024
Amplatz Goose Neck Snare Kit
K241259 · MMX
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jun 03, 2024
ANNE Chest
K240251 · DRG
Sibel Health, Inc.
Cardiovascular · 125d
Cleared May 31, 2024
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
K241248 · DWF
Spectrum Medical S.R.L.
Cardiovascular · 28d
Cleared May 31, 2024
Blood Pressure Monitor (TMB-2296-BT)
K240254 · DXN
Guangdong Transtek Medical...
Cardiovascular · 121d
Cleared CT May 31, 2024
Ringer perfusion balloon catheter, 2.00 x 20mm (5881)
K233729 · LOX
Vascular Solutions, LLC
Cardiovascular · 192d
Cleared May 30, 2024
The Circadia C200 System
K234003 · DRT
Circadia Technologies, Ltd.
Cardiovascular · 163d
Cleared May 29, 2024
SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy...
K241207 · QEW
Devoro Medical, Inc.
Cardiovascular · 29d
Cleared CT May 28, 2024
ANNE Limb
K240305 · DQA
Sibel Health, Inc.
Cardiovascular · 116d
Cleared May 28, 2024
SpiroSphere, SpiroSphereECG, CardioSphere
K223629 · BTY
Eresearchtechnology GmbH
Cardiovascular · 540d
Cleared May 24, 2024
PacePro Wire
K240864 · DQX
Opsens, Inc.
Cardiovascular · 57d
Cleared May 24, 2024
INSPIRA ART100
K232788 · DWA
Inspira Technologies Oxy B.H.N. , Ltd.
Cardiovascular · 256d