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
2161–2184 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 20, 2019
Medtronic 6F Taiga Guiding Catheter
K192296 · DQY
Medtronic Vascular
Cardiovascular · 28d
Cleared Sep 19, 2019
Sapphire NC Plus Coronary Dilatation Catheter
K192344 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 21d
Cleared Sep 17, 2019
Advisor VL Circular Mapping Catheter, Sensor Enabled
K192037 · DRF
Abbott Medical
Cardiovascular · 49d
Cleared Sep 17, 2019
Reusable NIBP Cuff
K191253 · DXQ
Shenzhen Changke Connect Electronics...
Cardiovascular · 131d
Cleared Sep 17, 2019
Sim&Size
K190049 · PZO
Sim&Cure
Cardiovascular · 250d
Cleared Sep 16, 2019
Full Automatic (NIBP) Blood Pressure Monitor
K190507 · DXN
Health & Life Co., Ltd.
Cardiovascular · 199d
Cleared Sep 13, 2019
Multi-Link X2 ECG and SpO2 Adapter
K191273 · DSA
Vyaire Medical, Inc.
Cardiovascular · 123d
Cleared Sep 13, 2019
ACIST RXi System and Navvus II Catheter
K190473 · OBI
Acist Medical Systems, Inc.
Cardiovascular · 198d
Cleared CT Sep 12, 2019
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy...
K191419 · MCW
Rex Medical, L.P.
Cardiovascular · 107d
Cleared Sep 11, 2019
CNAP Monitor
K183521 · DXN
Cnsystems Medizintechnik GmbH
Cardiovascular · 266d
Cleared Sep 11, 2019
PeraMobile and PeraWatch
K183370 · MWI
Perahealth, Inc.
Cardiovascular · 281d
Cleared Sep 10, 2019
External Counterpulsation System
K190683 · DRN
Vamed Medical Instrument Co., Ltd.
Cardiovascular · 176d
Cleared Sep 06, 2019
AcQMap High Resolution Imaging and Mapping System
K191392 · DQK
Acutus Medical, Inc.
Cardiovascular · 105d
Cleared Sep 06, 2019
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574 · DPW
Huntleigh Healthcare , Ltd.
Cardiovascular · 259d
Cleared Sep 06, 2019
Steerable catheter control system
K183027 · PJB
Stereotaxis, Inc.
Cardiovascular · 309d
Cleared Sep 05, 2019
FlowTriever Retrieval/Aspiration System
K191710 · QEW
Inari Medical
Cardiovascular · 71d
Cleared Sep 03, 2019
AcQRef Introducer Sheath
K192106 · DYB
Acutus Medical, Inc.
Cardiovascular · 29d
Cleared Sep 03, 2019
Geomed Vascular Dilators
K183438 · DWP
Geomed Medizin-Technik GmbH & Co.
Cardiovascular · 265d
Cleared Aug 30, 2019
EV1000 Clinical Platform NI, EV1000 Clinical Platform
K192058 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Aug 30, 2019
Carnation Ambulatory Monitor
K191471 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 88d
Cleared Aug 29, 2019
ClotTriever Thrombectomy System
K192036 · QEW
Inari Medical
Cardiovascular · 30d
Cleared Aug 29, 2019
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
K190205 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 206d
Cleared Aug 28, 2019
Delta 3300
K190437 · DRL
Netech Corporation
Cardiovascular · 187d
Cleared Aug 28, 2019
B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T...
K182401 · MWI
Amzetta Technologies Private Limited
Cardiovascular · 358d