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
2401–2424 of 18,110
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 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