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
2977–3000 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 08, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162915 · DXN
Andon Health Co, Ltd.
Cardiovascular · 114d
Cleared Feb 08, 2017
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K161577 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 246d
Cleared Feb 03, 2017
TrapLiner catheter
K161901 · DQY
Vascular Solutions, Inc.
Cardiovascular · 207d
Cleared Feb 03, 2017
Telemetry Transmitter
K161056 · MHX
Edan Instruments, Inc.
Cardiovascular · 295d
Cleared Feb 02, 2017
FlexCath Select Steerable Shealth and Dilator
K163268 · DYB
Medtronic Cryocath, LP
Cardiovascular · 73d
Cleared Feb 01, 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
K162958 · DTR
Medtronic, Inc.
Cardiovascular · 100d
Cleared Feb 01, 2017
Twin-Pass Torque
K162467 · DQY
Vascular Solutions, Inc.
Cardiovascular · 152d
Cleared Feb 01, 2017
iHealth Wireless Blood Pressure Monitor
K162144 · DXN
Andon Health Co, Ltd.
Cardiovascular · 184d
Cleared Jan 31, 2017
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion...
K163542 · DSP
Datascope Corp.
Cardiovascular · 46d
Cleared Jan 30, 2017
Radifocus Glidewire Advantage Track
K163004 · DQX
Ashitaka Factory of Terumo Coporation
Cardiovascular · 94d
Cleared Jan 27, 2017
ASAHI PTCA Guide Wire ASAHI SUOH 03
K162842 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 108d
Cleared Jan 27, 2017
Vado Bi-Directional Steerable Sheath
K162427 · DYB
Kalila Medical, Inc.
Cardiovascular · 150d
Cleared Jan 27, 2017
Ecomed Disposable Angiographic Syringes
K162088 · DXT
Ecomed Solutions, LLC
Cardiovascular · 183d
Cleared Jan 27, 2017
FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
K161967 · KRA
Callisyn Biomedical, Inc.
Cardiovascular · 193d
Cleared Jan 27, 2017
Philips IntelliVue GuardianSoftware
K161767 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 214d
Cleared Jan 26, 2017
IntraClude Intra-Aortic Occlusion Device
K163693 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Jan 26, 2017
Pantera LEO
K163660 · LOX
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jan 25, 2017
PreludeSYNC Radial Compression Device
K162988 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Jan 19, 2017
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD...
K163620 · JOW
Covidien
Cardiovascular · 28d
Cleared Jan 19, 2017
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
K163113 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 73d
Cleared Jan 19, 2017
NC Gallant PTCA Catheter
K162434 · LOX
Medinol, Ltd.
Cardiovascular · 141d
Cleared Jan 19, 2017
Medline Waste Station
K160660 · DQO
Medline Industries, Inc.
Cardiovascular · 317d
Cleared Jan 18, 2017
Quantum Workstation
K163657 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 26d
Cleared Jan 18, 2017
Multi-Link X2 ECG Cable and Lead Wire System
K162432 · DSA
Carefusion 2200, Inc.
Cardiovascular · 140d