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
433–456 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 20, 2025
VitalFlow Console
K250199 · QNR
Medtronic, Inc.
Cardiovascular · 117d
Cleared May 16, 2025
Embosphere Microspheres
K250971 · KRD
Biosphere Medical, S.A.
Cardiovascular · 46d
Cleared May 16, 2025
iBSM
K243837 · DRG
Iorbit Digital Technologies Private...
Cardiovascular · 154d
Cleared May 15, 2025
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · LDF
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared May 15, 2025
Nitinol Enhanced Device (NED)
K250276 · KRD
Embolization, Inc.
Cardiovascular · 104d
Cleared May 15, 2025
Hypertension Prediction Index (HePI) Algorithm
K242518 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared May 14, 2025
Symphony™ Thrombectomy System
K250775 · QEW
Imperative Care, Inc.
Cardiovascular · 61d
Cleared May 12, 2025
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
K250592 · OWQ
Northeast Scientific, Inc.
Cardiovascular · 74d
Cleared May 12, 2025
InThrill™ Thrombectomy System
K250421 · QEW
Inari Medical, Inc.
Cardiovascular · 88d
Cleared May 09, 2025
VeriSight Intracardiac Echocardiography Catheter (VSICE2D)
K251103 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 28d
Cleared May 09, 2025
Volta AF-Xplorer
K243812 · DQK
Volta Medical
Cardiovascular · 149d
Cleared May 09, 2025
Avidhrt Sense SpO2
K241086 · DQA
Avidhrt, Inc.
Cardiovascular · 385d
Cleared May 05, 2025
Telemetry Monitor 5500 Release 4.0 (867232)
K242962 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 222d
Cleared May 02, 2025
Wrist Blood Pressure Monitor (AOJ-35A)
K250161 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 101d
Cleared May 02, 2025
Shockwave CS Guide Catheter
K243757 · DQY
Shockwave Medical, Inc.
Cardiovascular · 147d
Cleared May 02, 2025
AT-Patch (ATP-C130/ATP-C70)
K242583 · DSH
Atsens Co., Ltd.
Cardiovascular · 245d
Cleared May 01, 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
K251007 · DXF
Circa Scientific, Inc.
Cardiovascular · 30d
Cleared Apr 30, 2025
AuST Steerable Sheath
K251051 · DYB
CenterPoint Systems, LLC
Cardiovascular · 27d
Cleared Apr 30, 2025
Arm Blood Pressure Monitor (ARM-30A+)
K244000 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 125d
Cleared Apr 30, 2025
Arctic Sun Stat Temperature Management System
K243942 · DWJ
Medivance, Inc.
Cardiovascular · 131d
Cleared Apr 25, 2025
Prelude Wave Hydrophilic Sheath Introducer
K250909 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Apr 25, 2025
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere...
K250723 · MCW
Cardio Flow Inc.,
Cardiovascular · 46d
Cleared Apr 25, 2025
Amulet™ Steerable Delivery Sheath
K250426 · DQY
Abbott Medical
Cardiovascular · 70d
Cleared Apr 24, 2025
Arm Blood Pressure Monitor (ARM-30H)
K250116 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 98d