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
913–936 of 18,182
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