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
3673–3696 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 09, 2015
ENROUTE Transcarotid Neuroprotection System
K143072 · NTE
Silk Road Medical, Inc.
Cardiovascular · 105d
Cleared Feb 06, 2015
CLEO PATIENT MONITOR
K142244 · MWI
Infinium Medical
Cardiovascular · 177d
Cleared Feb 06, 2015
ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
K141492 · DTZ
Eurosets S.R.L
Cardiovascular · 246d
Cleared Feb 05, 2015
12SL ECG ANALYSIS PROGRAM
K141963 · MHX
Ge Medical Systems Information...
Cardiovascular · 202d
Cleared Feb 03, 2015
Infusion Aspiration Catheter System
K143563 · QEW
Inari Medical, Inc.
Cardiovascular · 49d
Cleared Feb 03, 2015
Ebony PTA 0.014 RX Peripheral Dilatation Catheter
K142459 · LIT
Natec Medical , Ltd.
Cardiovascular · 154d
Cleared Jan 30, 2015
NAVAJO PTA BALLOON DILATATION CATHETER
K141354 · DQY
Curative Medical, Inc.
Cardiovascular · 252d
Cleared Jan 30, 2015
VECTRAPLEX CMS
K140852 · MSX
Vectracor, Inc.
Cardiovascular · 302d
Cleared Jan 29, 2015
One Way Soft Valve
K142500 · MJJ
Terumo Cardiovascular Systems...
Cardiovascular · 146d
Cleared Jan 29, 2015
TRANSONIC ELSA SYSTEM
K134051 · DXG
Transonic Systems, Inc.
Cardiovascular · 394d
Cleared Jan 27, 2015
AliveCor Heart Monitor
K142743 · DXH
AliveCor, Inc.
Cardiovascular · 125d
Cleared Jan 26, 2015
Benchmark Intracranial Access System
K142321 · DQY
Penumbra, Inc.
Cardiovascular · 160d
Cleared Jan 26, 2015
CROC
K141685 · DXC
Combat Medical Systems, LLC
Cardiovascular · 217d
Cleared Jan 23, 2015
Visi Mobile Monitoring System
K143751 · MWI
Sotera Wireless, Inc.
Cardiovascular · 23d
Cleared Jan 23, 2015
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
K133659 · MKJ
Philips Medical Systems
Cardiovascular · 422d
Cleared Jan 22, 2015
Deltex Medical KDP72 Doppler Probe
K142932 · DPT
Deltex Medical Limited
Cardiovascular · 105d
Cleared Jan 22, 2015
DIGITAL ELECTROCARDIOGRAPH
K133985 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 392d
Cleared Jan 21, 2015
ULTRASKIN HYDROPHILIC GUIDE WIRE
K141707 · DQX
Lepu Medical Technology (Beijing)...
Cardiovascular · 211d
Cleared Jan 20, 2015
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
K143317 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 62d
Cleared Jan 18, 2015
TruWave Disposable Pressure Transducer
K142749 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 116d
Cleared Jan 18, 2015
DECISIO HEALTH PATIENT DASHBOARD
K142106 · MWI
Decisio Health, Inc.
Cardiovascular · 170d
Cleared Jan 16, 2015
Medline ReNewal Reprocessed Compression Limb Sleeves
K143166 · JOW
Surgical Instrument Service and...
Cardiovascular · 73d
Cleared Jan 16, 2015
ZOLL E SERIES
K133239 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 452d
Cleared Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire,...
K143587 · DQX
Boston Scientific Corporation
Cardiovascular · 28d