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
697–720 of 18,110
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 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 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