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
3265–3288 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 17, 2016
Axeo 3 Patient Monitor
K153079 · MWI
Axeo Medical Technologies, LLC
Cardiovascular · 146d
Cleared Mar 17, 2016
LiDCOunity Monitor
K152935 · DXG
Lidco, Ltd.
Cardiovascular · 164d
Cleared Mar 15, 2016
AlertWatch: OR
K153335 · MWI
Alertwatch, LLC
Cardiovascular · 117d
Cleared Mar 15, 2016
MODEL 621/624 BIOMAGNETOMETER
K151135 · DPS
Tristan Technologies, Inc.
Cardiovascular · 321d
Cleared Mar 14, 2016
Reprocessed Electrophysiology Catheter
K153153 · NLH
Innovative Health, LLC
Cardiovascular · 133d
Cleared Mar 13, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160145 · DXN
Health & Life Co., Ltd.
Cardiovascular · 52d
Cleared Mar 11, 2016
Surefire Infusion System
K160662 · DQO
Surefire Medical, Inc.
Cardiovascular · 2d
Cleared Mar 11, 2016
NovaCross Microcatheter
K160389 · DQY
Nitiloop , Ltd.
Cardiovascular · 29d
Cleared Mar 11, 2016
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
K160064 · QYX
Infobionic, Inc.
Cardiovascular · 58d
Cleared Mar 10, 2016
ENROUTE Transcarotid Neuroprotection System
K153485 · NTE
Silk Road Medical, Inc.
Cardiovascular · 98d
Cleared Mar 10, 2016
Reprocessed Diagnostic Ultrasound Catheter
K153090 · OWQ
Innovative Health, LLC
Cardiovascular · 136d
Cleared Mar 09, 2016
MMS Guide Catheter
K152625 · KRA
Micro Medical Solutions, Inc.
Cardiovascular · 176d
Cleared Mar 07, 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
K153430 · DYB
Cook Incorporated
Cardiovascular · 103d
Cleared Mar 04, 2016
Endophys Pressure Sensing Sheath Kit
K160272 · DYB
Endophys, Inc.
Cardiovascular · 31d
Cleared Mar 04, 2016
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
K160257 · DWF
Cardiacassist, Inc.
Cardiovascular · 32d
Cleared Mar 04, 2016
MultiCross Catheter
K152957 · DQY
Roxwood Medical, Inc.
Cardiovascular · 149d
Cleared Mar 04, 2016
ASAHI Corsair Armet
K152249 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 03, 2016
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 94d
Cleared Mar 01, 2016
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
K153460 · MCW
Avinger, Inc.
Cardiovascular · 91d
Cleared Feb 26, 2016
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz...
K160173 · DXK
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Feb 26, 2016
TandemLung Oxygenator
K153295 · DTZ
Cardiacassist, Inc.
Cardiovascular · 105d
Cleared Feb 26, 2016
Aingeal Activity System
K153275 · MHX
Intelesens, Ltd.
Cardiovascular · 106d
Cleared Feb 26, 2016
VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
K152765 · DTK
B. Braun Interventional Systems, Inc.
Cardiovascular · 155d
Cleared Feb 26, 2016
H3+ Holter Recorder
K152626 · MWJ
Mortara Instrument, Inc.
Cardiovascular · 164d