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
2473–2496 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 17, 2018
Full Automatic(NIBP) Blood Pressure Monitor
K180240 · DXN
Health & Life Co., Ltd.
Cardiovascular · 261d
Cleared Oct 15, 2018
FlowTriever Retrieval/Aspiration System
K182233 · QEW
Inari Medical
Cardiovascular · 59d
Cleared Oct 12, 2018
Radial Medical Compression System
K181651 · JOW
Radial Medical, Inc.
Cardiovascular · 112d
Cleared Oct 12, 2018
Endophys Pressure Sensing Sheath Kit
K180620 · DYB
Endophys Holdings, LLC
Cardiovascular · 217d
Cleared Oct 10, 2018
ClotTriever Thrombectomy System
K182531 · QEW
Inari Medical
Cardiovascular · 26d
Cleared Oct 10, 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289 · DXT
Shenzhen Baoan Medical Supplies Co.,...
Cardiovascular · 48d
Cleared Oct 10, 2018
CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7...
K181038 · PSQ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 174d
Cleared Oct 06, 2018
Bluetooth blood pressure monitor
K182018 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 71d
Cleared Oct 05, 2018
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model...
K181725 · PQK
Avenu Medical, Inc.
Cardiovascular · 98d
Cleared CT Oct 05, 2018
B-Laser Atherectomy System
K181642 · MCW
Eximo Medical, Ltd.
Cardiovascular · 106d
Cleared Oct 05, 2018
GORE Tri-Lumen Catheter
K180919 · DQY
W. L. Gore and Associates, Inc.
Cardiovascular · 179d
Cleared Oct 05, 2018
Royal Flush Plus High-Flow Catheter
K180054 · DQO
Cook Incorporated
Cardiovascular · 270d
Cleared Oct 03, 2018
Caretaker Remote Display App and Caretaker Software Library
K181196 · DRG
Caretaker Medical, LLC
Cardiovascular · 149d
Cleared Oct 01, 2018
MPS2 Myocardial Protection System Console
K173716 · DTR
Quest Medical, Inc.
Cardiovascular · 300d
Cleared Sep 28, 2018
TSP Crosser Transseptal Access System
K181088 · DYB
Transseptal Solutions , Ltd.
Cardiovascular · 156d
Cleared Sep 28, 2018
FibriCheck
K173872 · DXH
Qompium NV
Cardiovascular · 282d
Cleared Sep 27, 2018
EmboCube Embolization Gelatin
K181021 · KRD
Biosphere Medical, S.A.
Cardiovascular · 163d
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 26, 2018
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex...
K181563 · DQY
Access Scientific, LLC
Cardiovascular · 104d
Cleared Sep 20, 2018
Medline Patient Cables and Lead Wires
K181726 · DSA
Medline Industries, Inc.
Cardiovascular · 83d
Cleared Sep 18, 2018
The CVC WAND Safety Introducer with Valved Peelable Sheath
K182243 · DYB
Access Scientific, LLC
Cardiovascular · 29d
Cleared Sep 18, 2018
MAC VU360 Resting ECG Analysis System
K173830 · DPS
Ge Medical Systems Information...
Cardiovascular · 274d
Cleared Sep 11, 2018
Octane Mechanical Thrombectomy System
K182232 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 25d
Cleared Sep 11, 2018
AirStrip RPM InvisionHeart Adapter
K182226 · MWI
Airstrip Technologies, Inc.
Cardiovascular · 26d