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
1057–1080 of 18,110
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 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 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