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
1129–1152 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 02, 2023
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
K230292 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 89d
Cleared Apr 28, 2023
BNLE Access Guidewire
K221390 · DQX
Biomerics Nle
Cardiovascular · 350d
Cleared Apr 27, 2023
ClotTriever XL Catheter
K223210 · QEW
Inari Medical, Inc.
Cardiovascular · 192d
Cleared CT Apr 27, 2023
EmPro EPS (EP4514C-190, EP6514C-190)
K222694 · NTE
MicroVention, Inc.
Cardiovascular · 233d
Cleared Apr 26, 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
K230553 · MXD
Medtronic, Inc.
Cardiovascular · 57d
Cleared Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
K230594 · PDU
Avinger, Inc.
Cardiovascular · 53d
Cleared Apr 25, 2023
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
K230503 · DRF
Boston Scientific
Cardiovascular · 60d
Cleared Apr 24, 2023
RAIN Sheath™ Tibial Pedal Introducer
K230704 · DYB
Cordis US Corp
Cardiovascular · 41d
Cleared Apr 24, 2023
The Heart Seat
K222330 · MWI
Casana Care, Inc.
Cardiovascular · 265d
Cleared Apr 21, 2023
CONNEQT PULSE
K221742 · DXN
Atcor Medical
Cardiovascular · 310d
Cleared CT Apr 20, 2023
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter,...
K222095 · QEY
Thrombolex, Inc.
Cardiovascular · 276d
Cleared Apr 20, 2023
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · DWP
Fehling Surgical Instruments, Inc.
Cardiovascular · 381d
Cleared Apr 19, 2023
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO)...
K223168 · QWF
Medtronic, Inc.
Cardiovascular · 190d
Cleared Apr 18, 2023
Anivia SG1000 Pump Console
K230698 · DWA
Apmtd, Inc.
Cardiovascular · 36d
Cleared Apr 18, 2023
ClotTriever BOLD Catheter
K230494 · QEW
Inari Medical, Inc.
Cardiovascular · 54d
Cleared Apr 18, 2023
Terumo Advanced Perfusion System 1
K221895 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 292d
Cleared Apr 14, 2023
Dragonfly OpStar™ Imaging Catheter
K230411 · DQO
Abbott Medical
Cardiovascular · 58d
Cleared Apr 14, 2023
N9+
K223785 · DQD
Nonagon , Ltd.
Cardiovascular · 119d
Cleared Apr 13, 2023
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879 · DTR
Quara S.R.L.
Cardiovascular · 107d
Cleared Apr 13, 2023
Stratus Infusion Catheter
K222185 · NPG
Intervene, Inc.
Cardiovascular · 265d
Cleared Apr 12, 2023
Task Force CORE
K223332 · DXN
Cnsystems Medizintechnik GmbH
Cardiovascular · 163d
Cleared Apr 11, 2023
POT PTCA Balloon Dilatation Catheter
K230705 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 28d
Cleared Apr 11, 2023
ENROUTE® Transcarotid Neuroprotection System
K230402 · NTE
Silk Road Medical
Cardiovascular · 55d
Cleared Apr 10, 2023
Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner...
K223176 · KRA
Argon Medical Devices, Inc.
Cardiovascular · 181d