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
2089–2112 of 18,110
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 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