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
841–864 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 11, 2023
FARADRIVE™ Steerable Sheath
K233248 · DRA
Boston Scientific Corporation
Cardiovascular · 74d
Cleared Dec 11, 2023
Wrist Blood Pressure Monitor
K232815 · DXN
Zhuhai Yueja Medical Device...
Cardiovascular · 89d
Cleared Dec 08, 2023
10F Sheath and Dilator Set
K233432 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 57d
Cleared Dec 08, 2023
SimpleSense-BP, SimpleSense-BP Software Application
K232053 · DXN
Nanowear, Inc.
Cardiovascular · 150d
Cleared Dec 07, 2023
DLP Silicone Coronary Artery Ostial Cannulae
K231206 · DWF
Medtronic, Inc.
Cardiovascular · 224d
Cleared Dec 06, 2023
LINQ II Insertable Cardiac Monitor
K233562 · MXD
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 06, 2023
QT ECG (QTERD100)
K233521 · DXH
QT Medical, Inc.
Cardiovascular · 35d
Cleared Dec 05, 2023
Electronic Blood Pressure Monitor
K232814 · DXN
Zhuhai Yueja Medical Device...
Cardiovascular · 83d
Cleared Dec 05, 2023
Electronic Blood Pressure Monitor, model: HTD6602US
K223170 · DXN
Hetaida Technology Co., Ltd.
Cardiovascular · 420d
Cleared Dec 02, 2023
Cosine-10TM Diagnostic Catheter
K233397 · DRF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Dec 01, 2023
Medline ComfortTemp Patient Warming System
K231211 · DWJ
Medline Industries, LP
Cardiovascular · 217d
Cleared Nov 30, 2023
14F iSLEEVE Introducer Set
K233503 · DYB
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Nov 29, 2023
Blood Pressure Cuff...
K232772 · DXQ
Shenzhen Plinma Technology Co. , Ltd.
Cardiovascular · 79d
Cleared Nov 29, 2023
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S,...
K231821 · KRA
Transit Scientific, LLC
Cardiovascular · 161d
Cleared Nov 28, 2023
Blood Pressure Monitor
K232713 · DXN
Guangdong Transtek Medical...
Cardiovascular · 84d
Cleared Nov 28, 2023
Digital Blood Pressure Monitor
K231250 · DXN
Guangdong Genial Technology Co., Ltd.
Cardiovascular · 211d
Cleared Nov 27, 2023
ABPMpro
K231104 · DSH
Somnomedics GmbH
Cardiovascular · 222d
Cleared Nov 25, 2023
NeuTrace EP Mapping System v.2.1
K233160 · DQK
Anumana, Inc.
Cardiovascular · 59d
Cleared Nov 22, 2023
Carnation Ambulatory Monitor
K233110 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 56d
Cleared Nov 22, 2023
Blood pressure monitor
K232621 · DXN
Guangdong Transtek Medical...
Cardiovascular · 85d
Cleared Nov 22, 2023
Digital Blood Pressure Monitor (Arm Type)
K231245 · DXN
Guangdong Genial Technology Co., Ltd.
Cardiovascular · 205d
Cleared Nov 22, 2023
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement...
K230604 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 264d
Cleared Nov 22, 2023
Fogg System Patient Monitoring Cables
K222712 · DSA
Fogg System Company, Inc.
Cardiovascular · 440d
Cleared Nov 21, 2023
INFINITI™ Ambi Angiographic Catheter
K232573 · DQO
Cordis US Corp
Cardiovascular · 88d